A Prospective, Randomized, Placebo and Active Comparator... | NCT00784719 | Trialant
NCT00784719
Sponsor
Pfizer
Status
Completed
Last Update Posted
Apr 9, 2013Estimated
Enrollment
327Actual
Phase
Phase 1Phase 2
Conditions
Dry Eye Syndromes
Interventions
CP-690,550
CP-690,550
CP-690,550
CP-690,550
Cyclosporine
CP-690,550 Vehicle
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00784719
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
A3921034
Secondary IDs
ID
Type
Description
Link
A3921034
Brief Title
A Prospective, Randomized, Placebo and Active Comparator Controlled Study of CP-690,550 in Subjects With Dry Eye.
Official Title
A Phase I/II Prospective, Randomized, Double Masked, Vehicle And Comparator Controlled, Dose Ranging Study Of CP-690,550 In Subjects With Dry Eye Disease.
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Feb 2013
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 2008
Primary Completion Date
Oct 2009Actual
Completion Date
Oct 2009Actual
First Submitted Date
Nov 3, 2008
First Submission Date that Met QC Criteria
Nov 3, 2008
First Posted Date
Nov 4, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 29, 2012
Results First Submitted that Met QC Criteria
Feb 27, 2013
Results First Posted Date
Apr 9, 2013Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Mar 24, 2011
Certification/Extension First Submitted that Passed QC Review
Mar 24, 2011
Certification/Extension First Posted Date
Apr 1, 2011Estimated
Last Update Submitted Date
Feb 27, 2013
Last Update Posted Date
Apr 9, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
A prospective, randomized, placebo and active comparator controlled study of CP-690,550 in subjects with dry eye.
Detailed Description
Not provided
Conditions Module
Conditions
Dry Eye Syndromes
Keywords
Dry eye
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
327Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Treatment 1
Experimental
Drug: CP-690,550
Treatment 2
Experimental
Drug: CP-690,550
Treatment 3
Experimental
Drug: CP-690,550
Treatment 4
Experimental
Drug: CP-690,550
Active comparator
Active Comparator
Drug: Cyclosporine
Placebo
Placebo Comparator
Drug: CP-690,550 Vehicle
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CP-690,550
Drug
Ophthalmic topical solution, low dose, dosed at least once/day, 8 weeks
Treatment 1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Systemic Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic AEs are the events which are not localized but occur throughout the systemic circulation.
Baseline up to Week 8
Percentage of Participants With Ocular Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Ocular AEs are the events which are localized in the ocular region.
Baseline up to Week 8
Percentage of Participants With Ocular Tolerability Assessment
Ocular tolerability assessment included evaluation of severity and duration of the 5 symptoms: burning/stinging, blurred vision, ocular discomfort, pain, tearing. Severity was assessed on a 4-point scale, where 0=none, 1=mild, 2=moderate and 3=severe. Duration was assessed as immediate (if subsided within 5 minutes [<5 min] after application) or persistent (if continued beyond 5 minutes [>=5 min] after application).
Baseline up to Week 8
Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8
Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 millimeter (mm). If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Week 8
Secondary Outcomes
Measure
Description
Time Frame
Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia
Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Symptoms of dry eye for at least 6 months.
Signs of moderate to severe dry eye
Exclusion Criteria:
Women who are nursing or pregnant
Participation in other studies within 30 days of screening visit
Ocular disorders that may confound interpretation of study results
Liew MS, Zhang M, Kim E, Akpek EK. Prevalence and predictors of Sjogren's syndrome in a prospective cohort of patients with aqueous-deficient dry eye. Br J Ophthalmol. 2012 Dec;96(12):1498-503. doi: 10.1136/bjophthalmol-2012-301767. Epub 2012 Sep 21.
One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
FG001
CP-690,550, 0.0003% Twice Daily
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
2
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
CP-690,550
Drug
Ophthalmic topical solution, medium dose, dosed at least once/day, 8 weeks
Treatment 2
CP-690,550
Drug
Ophthalmic topical solution, intermediate dose, dosed at least once/day, 8 weeks
Treatment 3
CP-690,550
Drug
Ophthalmic topical solution, high dose, dosed at least once/day, 8 weeks
Treatment 4
Cyclosporine
Drug
Ophthalmic topical solution, 0.05%, dosed at least once/day, 8 weeks
Active comparator
CP-690,550 Vehicle
Drug
Ophthalmic topical solution, dosed at least once/day, 8 weeks
Placebo
Baseline through Week 8
Time to Achieve 100 Percent (%) Clearance of Corneal Staining
Corneal staining was assessed by instilling sodium fluorescein dye in the eye and after 1 to 2 minutes, observing for corneal staining with the aid of a yellow filter and slit lamp. The cornea was divided into five different zones and each corneal zone was graded independently using a 0 to 3 grading scale; where 0=none, 1=slight, 2=moderate, 3=severe. Results from study eye were to be reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Baseline through Week 8
Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score
OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contained 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.
Baseline through Week 8
Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8
Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Baseline, Week 1, 2, 4, 6, 8
Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8
Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Baseline, Week 8
Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6
Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Week 1, 2, 4, 6
Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8
Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Week 8
Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8
Corneal staining was assessed using fluorescein dye, a yellow filter, and a slit lamp. The cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale; where 0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Baseline, Week 1, 2, 4, 6, 8
Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining
Corneal staining was assessed using fluorescein dye, yellow filter, slit lamp. Cornea was divided into 5 different zones. Each corneal zone was graded independently using 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Week 1, 2, 4, 6, 8
Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8
Interpalpebral conjunctival staining was performed 1 minute following ocular administration of lissamine green dye with aid of slit lamp. Based on Oxford grading system, bulbar conjunctiva was divided into 2 zones: nasal, temporal. Staining were graded using a 6-point scale (0=absent, 5=severe). Total score=sum of 2 zone scores. Total score range: 0 to 10, higher score=higher damage to eyes due to dryness. Negative change from baseline indicated improvement. Results from study eye are reported. Study eye is the eye with worse Schirmer test score without anesthesia score at baseline.
Baseline, Week 1, 2, 4, 6, 8
Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8
TBUT was the time interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. It was measured under a slit lamp following instillation of fluorescein dye in the eye using a stopwatch. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
Baseline, Week 1, 2, 4, 6, 8
Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8
OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.
Baseline, Week 1, 2, 4, 6, 8
Percentage of Participants With >= 5 Units Decrease in Total OCI Score
OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort.
Week 1, 2, 4, 6, 8
Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8
Daily artificial tear use was assessed by collecting data on daily number of drops of artificial tear instilled in the eye using a participant diary. Decrease in daily artificial tear use indicated improvement.
Baseline, Week 1, 2, 4, 6, 8
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
OSDI is a validated instrument for ocular surface disease. It has 12 items, each measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score (question 1 [Q1]-Q12) and three subscale scores can be derived: Ocular Symptom (Q1-Q3), Vision-related function (Q4-Q9), and Environmental trigger (Q10-Q12). Each derived score ranges from 0 to 100, with a higher score indicates worse condition.
Baseline, Week 1, 2, 4, 6, 8
Percentage of Participants With >= 10 Units Decrease in Total OSDI Score
OSDI is a validated instrument for ocular surface disease. It has 12 items, each has a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score can be derived which ranges from 0 to 100; a higher score indicates worse ocular disease.
Week 1, 2, 4, 6, 8
Change From Baseline Ocular Surface Disease Index (OSDI) Raw Score at Week 1, 2, 4, 6 and 8
OSDI is a validated instrument for ocular surface disease. It has 12 items, each with a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time).
Baseline, Week 1, 2, 4, 6, 8
Change From Baseline in Modified Ocular Comfort Index (mOCI) Raw Scores at Week 1, 2, 4, 6 and 8
mOCI consisted of the original 12-item OCI plus additional questions on other dry eye symptoms and their impact to participant's life. Each item was measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Negative change from baseline indicated improvement.
Baseline, Week 1, 2, 4, 6, 8
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: general health (GH), general vision (GV), ocular pain (OP), near activities (NAct), distance activities (DA), social functioning (SF), mental health (MH), role difficulties (RD), dependency, driving, color vision (CV) and peripheral vision (PV). Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, higher score=less symptoms/better visual functioning.
Liew SH, Nichols KK, Klamerus KJ, Li JZ, Zhang M, Foulks GN. Tofacitinib (CP-690,550), a Janus kinase inhibitor for dry eye disease: results from a phase 1/2 trial. Ophthalmology. 2012 Jul;119(7):1328-35. doi: 10.1016/j.ophtha.2012.01.028. Epub 2012 Apr 22.
FG002
CP-690,550, 0.001% Twice Daily
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
FG003
CP-690,550, 0.003% Twice Daily
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
FG004
CP-690,550, 0.005% Twice Daily
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
FG005
CP-690,550, 0.005% Once Daily
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
FG006
Restasis Twice Daily
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
FG00047 subjects
FG00146 subjects
FG00247 subjects
FG00348 subjects
FG00448 subjects
FG00544 subjects
FG00647 subjects
COMPLETED
FG00044 subjects
FG00143 subjects
FG00246 subjects
FG00348 subjects
FG00442 subjects
FG00541 subjects
FG00642 subjects
NOT COMPLETED
FG0003 subjects
FG0013 subjects
FG0021 subjects
FG0030 subjects
FG0046 subjects
FG0053 subjects
FG0065 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0061 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo Twice Daily
One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
BG001
CP-690,550, 0.0003% Twice Daily
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
BG002
CP-690,550, 0.001% Twice Daily
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
BG003
CP-690,550, 0.003% Twice Daily
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
BG004
CP-690,550, 0.005% Twice Daily
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
BG005
CP-690,550, 0.005% Once Daily
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
BG006
Restasis Twice Daily
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00047
BG00146
BG00247
BG00348
BG00448
BG00544
BG00647
BG007327
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00062.3± 12.54
BG00159.5± 11.57
BG00260.7± 11.73
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00032
BG00135
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With Systemic Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic AEs are the events which are not localized but occur throughout the systemic circulation.
Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study medication.
Posted
Number
percentage of participants
Baseline up to Week 8
ID
Title
Description
OG000
Placebo Twice Daily
One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
OG001
CP-690,550, 0.0003% Twice Daily
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
OG002
CP-690,550, 0.001% Twice Daily
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
OG003
CP-690,550, 0.003% Twice Daily
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
OG004
CP-690,550, 0.005% Twice Daily
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
OG005
CP-690,550, 0.005% Once Daily
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
OG006
Restasis Twice Daily
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Units
Counts
Participants
OG00047
OG00146
OG00247
OG003
Title
Denominators
Categories
Title
Measurements
OG00027.7
OG0018.7
OG00229.8
OG003
Primary
Percentage of Participants With Ocular Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Ocular AEs are the events which are localized in the ocular region.
ITT population included all enrolled participants who received at least 1 dose of study medication.
Posted
Number
percentage of participants
Baseline up to Week 8
ID
Title
Description
OG000
Placebo Twice Daily
One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
OG001
CP-690,550, 0.0003% Twice Daily
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
OG002
CP-690,550, 0.001% Twice Daily
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
OG003
CP-690,550, 0.003% Twice Daily
Primary
Percentage of Participants With Ocular Tolerability Assessment
Ocular tolerability assessment included evaluation of severity and duration of the 5 symptoms: burning/stinging, blurred vision, ocular discomfort, pain, tearing. Severity was assessed on a 4-point scale, where 0=none, 1=mild, 2=moderate and 3=severe. Duration was assessed as immediate (if subsided within 5 minutes [<5 min] after application) or persistent (if continued beyond 5 minutes [>=5 min] after application).
ITT population included all enrolled participants who received at least one dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Number
percentage of participants
Baseline up to Week 8
ID
Title
Description
OG000
Placebo Twice Daily
One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
OG001
CP-690,550, 0.0003% Twice Daily
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
OG002
CP-690,550, 0.001% Twice Daily
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
Primary
Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8
Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 millimeter (mm). If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
ITT population included all enrolled participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) was the method used for imputing missing data at Week 8.
Posted
Number
percentage of participants
Week 8
ID
Title
Description
OG000
Placebo Twice Daily
One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
OG001
CP-690,550, 0.0003% Twice Daily
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
OG002
CP-690,550, 0.001% Twice Daily
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
Secondary
Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia
Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
ITT population included all enrolled participants who received at least 1 dose of study medication.
Posted
Median
95% Confidence Interval
days
Baseline through Week 8
ID
Title
Description
OG000
Placebo Twice Daily
One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
OG001
CP-690,550, 0.0003% Twice Daily
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
OG002
CP-690,550, 0.001% Twice Daily
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
OG003
Secondary
Time to Achieve 100 Percent (%) Clearance of Corneal Staining
Corneal staining was assessed by instilling sodium fluorescein dye in the eye and after 1 to 2 minutes, observing for corneal staining with the aid of a yellow filter and slit lamp. The cornea was divided into five different zones and each corneal zone was graded independently using a 0 to 3 grading scale; where 0=none, 1=slight, 2=moderate, 3=severe. Results from study eye were to be reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
ITT population included all enrolled participants who received at least 1 dose of study medication.
Posted
Median
95% Confidence Interval
days
Baseline through Week 8
ID
Title
Description
OG000
Placebo Twice Daily
One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
OG001
CP-690,550, 0.0003% Twice Daily
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
OG002
CP-690,550, 0.001% Twice Daily
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
Secondary
Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score
OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contained 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.
ITT population included all enrolled participants who received at least 1 dose of study medication.
Posted
Median
95% Confidence Interval
days
Baseline through Week 8
ID
Title
Description
OG000
Placebo Twice Daily
One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
OG001
CP-690,550, 0.0003% Twice Daily
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
OG002
CP-690,550, 0.001% Twice Daily
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
OG003
Secondary
Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8
Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.
Posted
Mean
Standard Deviation
mm
Baseline, Week 1, 2, 4, 6, 8
ID
Title
Description
OG000
Placebo Twice Daily
One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
OG001
CP-690,550, 0.0003% Twice Daily
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
OG002
CP-690,550, 0.001% Twice Daily
Secondary
Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8
Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
ITT population included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.
Posted
Mean
Standard Deviation
mm
Baseline, Week 8
ID
Title
Description
OG000
Placebo Twice Daily
One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
OG001
CP-690,550, 0.0003% Twice Daily
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
OG002
Secondary
Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6
Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
ITT population included all enrolled participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) included those participants who were evaluable for this measure.
Posted
Number
percentage of participants
Week 1, 2, 4, 6
ID
Title
Description
OG000
Placebo Twice Daily
One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
OG001
CP-690,550, 0.0003% Twice Daily
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
OG002
CP-690,550, 0.001% Twice Daily
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
Secondary
Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8
Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
ITT population included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.
Posted
Number
percentage of participants
Week 8
ID
Title
Description
OG000
Placebo Twice Daily
One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
OG001
CP-690,550, 0.0003% Twice Daily
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
OG002
CP-690,550, 0.001% Twice Daily
Secondary
Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8
Corneal staining was assessed using fluorescein dye, a yellow filter, and a slit lamp. The cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale; where 0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 1, 2, 4, 6, 8
ID
Title
Description
OG000
Placebo Twice Daily
One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
OG001
CP-690,550, 0.0003% Twice Daily
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
OG002
CP-690,550, 0.001% Twice Daily
Secondary
Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining
Corneal staining was assessed using fluorescein dye, yellow filter, slit lamp. Cornea was divided into 5 different zones. Each corneal zone was graded independently using 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.
Posted
Number
percentage of participants
Week 1, 2, 4, 6, 8
ID
Title
Description
OG000
Placebo Twice Daily
One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
OG001
CP-690,550, 0.0003% Twice Daily
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
OG002
CP-690,550, 0.001% Twice Daily
Secondary
Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8
Interpalpebral conjunctival staining was performed 1 minute following ocular administration of lissamine green dye with aid of slit lamp. Based on Oxford grading system, bulbar conjunctiva was divided into 2 zones: nasal, temporal. Staining were graded using a 6-point scale (0=absent, 5=severe). Total score=sum of 2 zone scores. Total score range: 0 to 10, higher score=higher damage to eyes due to dryness. Negative change from baseline indicated improvement. Results from study eye are reported. Study eye is the eye with worse Schirmer test score without anesthesia score at baseline.
ITT population. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 1, 2, 4, 6, 8
ID
Title
Description
OG000
Placebo Twice Daily
One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
OG001
CP-690,550, 0.0003% Twice Daily
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
OG002
Secondary
Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8
TBUT was the time interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. It was measured under a slit lamp following instillation of fluorescein dye in the eye using a stopwatch. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.
Posted
Mean
Standard Deviation
seconds
Baseline, Week 1, 2, 4, 6, 8
ID
Title
Description
OG000
Placebo Twice Daily
One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
OG001
CP-690,550, 0.0003% Twice Daily
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
OG002
CP-690,550, 0.001% Twice Daily
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
Secondary
Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8
OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.
ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 1, 2, 4, 6, 8
ID
Title
Description
OG000
Placebo Twice Daily
One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
OG001
CP-690,550, 0.0003% Twice Daily
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
OG002
CP-690,550, 0.001% Twice Daily
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
Secondary
Percentage of Participants With >= 5 Units Decrease in Total OCI Score
OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort.
ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.
Posted
Number
percentage of participants
Week 1, 2, 4, 6, 8
ID
Title
Description
OG000
Placebo Twice Daily
One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
OG001
CP-690,550, 0.0003% Twice Daily
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
OG002
CP-690,550, 0.001% Twice Daily
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
Secondary
Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8
Daily artificial tear use was assessed by collecting data on daily number of drops of artificial tear instilled in the eye using a participant diary. Decrease in daily artificial tear use indicated improvement.
ITT population. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.
Posted
Mean
Standard Deviation
drops/day
Baseline, Week 1, 2, 4, 6, 8
ID
Title
Description
OG000
Placebo Twice Daily
One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
OG001
CP-690,550, 0.0003% Twice Daily
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
OG002
CP-690,550, 0.001% Twice Daily
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
OG003
Secondary
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
OSDI is a validated instrument for ocular surface disease. It has 12 items, each measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score (question 1 [Q1]-Q12) and three subscale scores can be derived: Ocular Symptom (Q1-Q3), Vision-related function (Q4-Q9), and Environmental trigger (Q10-Q12). Each derived score ranges from 0 to 100, with a higher score indicates worse condition.
ITT population. LOCF method was used for imputing missing data at Week 8. Here 'N' (number of participants analyzed) included those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 1, 2, 4, 6, 8
ID
Title
Description
OG000
Placebo Twice Daily
One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
OG001
CP-690,550, 0.0003% Twice Daily
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
OG002
CP-690,550, 0.001% Twice Daily
Secondary
Percentage of Participants With >= 10 Units Decrease in Total OSDI Score
OSDI is a validated instrument for ocular surface disease. It has 12 items, each has a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score can be derived which ranges from 0 to 100; a higher score indicates worse ocular disease.
ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.
Posted
Number
percentage of participants
Week 1, 2, 4, 6, 8
ID
Title
Description
OG000
Placebo Twice Daily
One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
OG001
CP-690,550, 0.0003% Twice Daily
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
OG002
CP-690,550, 0.001% Twice Daily
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
Secondary
Change From Baseline Ocular Surface Disease Index (OSDI) Raw Score at Week 1, 2, 4, 6 and 8
OSDI is a validated instrument for ocular surface disease. It has 12 items, each with a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time).
Data for OSDI raw score was not analyzed due to the exploratory nature and overwhelming amount of data derived from the analysis.
Posted
Baseline, Week 1, 2, 4, 6, 8
ID
Title
Description
OG000
Placebo Twice Daily
One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
OG001
CP-690,550, 0.0003% Twice Daily
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
OG002
CP-690,550, 0.001% Twice Daily
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
OG003
CP-690,550, 0.003% Twice Daily
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
Secondary
Change From Baseline in Modified Ocular Comfort Index (mOCI) Raw Scores at Week 1, 2, 4, 6 and 8
mOCI consisted of the original 12-item OCI plus additional questions on other dry eye symptoms and their impact to participant's life. Each item was measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Negative change from baseline indicated improvement.
Data for mOCI raw score was not analyzed due to the exploratory nature and overwhelming amount of data derived from the analysis.
Posted
Baseline, Week 1, 2, 4, 6, 8
ID
Title
Description
OG000
Placebo Twice Daily
One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
OG001
CP-690,550, 0.0003% Twice Daily
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
OG002
CP-690,550, 0.001% Twice Daily
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
OG003
CP-690,550, 0.003% Twice Daily
Secondary
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: general health (GH), general vision (GV), ocular pain (OP), near activities (NAct), distance activities (DA), social functioning (SF), mental health (MH), role difficulties (RD), dependency, driving, color vision (CV) and peripheral vision (PV). Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, higher score=less symptoms/better visual functioning.
ITT population included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.
Posted
Mean
Standard Deviation
Units on a scale
Baseline, Week 8
ID
Title
Description
OG000
Placebo Twice Daily
One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
OG001
CP-690,550, 0.0003% Twice Daily
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
Time Frame
Not provided
Description
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo Twice Daily
One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
0
47
23
47
EG001
CP-690,550, 0.0003% Twice Daily
One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
1
46
11
46
EG002
CP-690,550, 0.001% Twice Daily
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
0
47
22
47
EG003
CP-690,550, 0.003% Twice Daily
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
1
48
21
48
EG004
CP-690,550, 0.005% Twice Daily
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
1
48
15
48
EG005
CP-690,550, 0.005% Once Daily
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
1
44
15
44
EG006
Restasis Twice Daily
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
1
47
26
47
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diverticulitis
Infections and infestations
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG0031 affected48 at risk
EG0040 affected48 at risk
EG0050 affected44 at risk
EG0060 affected47 at risk
Pneumonia
Infections and infestations
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0011 affected46 at risk
EG0020 affected47 at risk
EG003
Drug exposure during pregnancy
Injury, poisoning and procedural complications
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Syncope
Nervous system disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Thrombosis
Vascular disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0011 affected46 at risk
EG0020 affected47 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Bradycardia
Cardiac disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG0030 affected48 at risk
EG0041 affected48 at risk
EG0050 affected44 at risk
EG0060 affected47 at risk
Ear disorder
Ear and labyrinth disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0011 affected46 at risk
EG0020 affected47 at risk
EG003
Abnormal sensation in eye, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0001 affected47 at risk
EG0010 affected46 at risk
EG0021 affected47 at risk
EG003
Asthenopia, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0011 affected46 at risk
EG0021 affected47 at risk
EG003
Blepharitis, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Cataract nuclear, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0001 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Chalazion, FELLOW EYE ONLY
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Conjunctival cyst, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Conjunctival hyperaemia, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0001 affected47 at risk
EG0010 affected46 at risk
EG0021 affected47 at risk
EG003
Conjunctival hyperaemia, FELLOW EYE ONLY
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0011 affected46 at risk
EG0020 affected47 at risk
EG003
Conjunctival hyperaemia, STUDY EYE ONLY
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0002 affected47 at risk
EG0010 affected46 at risk
EG0021 affected47 at risk
EG003
Conjunctival oedema, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Conjunctival oedema, FELLOW EYE ONLY
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Conjunctival oedema, STUDY EYE ONLY
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0011 affected46 at risk
EG0020 affected47 at risk
EG003
Corneal deposits, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0011 affected46 at risk
EG0020 affected47 at risk
EG003
Corneal disorder, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0011 affected46 at risk
EG0020 affected47 at risk
EG003
Corneal disorder, FELLOW EYE ONLY
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Corneal epithelium defect, FELLOW EYE ONLY
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Corneal erosion, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0012 affected46 at risk
EG0021 affected47 at risk
EG003
Corneal oedema, STUDY EYE ONLY
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0001 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Dry eye, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0002 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Erythema of eyelid, STUDY EYE ONLY
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0011 affected46 at risk
EG0020 affected47 at risk
EG003
Excessive eye blinking, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Eye disorder, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Eye irritation, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0001 affected47 at risk
EG0011 affected46 at risk
EG0021 affected47 at risk
EG003
Eye irritation, FELLOW EYE ONLY
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0001 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Eye pain, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0001 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Eye pain, FELLOW EYE ONLY
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Eye pruritus, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0021 affected47 at risk
EG003
Eye pruritus, FELLOW EYE ONLY
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0001 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Eye swelling, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0021 affected47 at risk
EG003
Eyelid disorder, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Eyelid irritation, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Eyelid irritation, FELLOW EYE ONLY
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Eyelid margin crusting, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Eyelid oedema, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Foreign body sensation in eyes, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0001 affected47 at risk
EG0011 affected46 at risk
EG0020 affected47 at risk
EG003
Iritis, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0011 affected46 at risk
EG0020 affected47 at risk
EG003
Lacrimation increased, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0021 affected47 at risk
EG003
Lacrimation increased, FELLOW EYE ONLY
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0022 affected47 at risk
EG003
Meibomian gland dysfunction, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0021 affected47 at risk
EG003
Meibomian gland dysfunction, FELLOW EYE ONLY
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0001 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Meibomian gland dysfunction, STUDY EYE ONLY
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0001 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Myodesopsia, FELLOW EYE ONLY
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0011 affected46 at risk
EG0021 affected47 at risk
EG003
Myodesopsia, STUDY EYE ONLY
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0001 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Ocular discomfort, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Ocular hyperaemia, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0012 affected46 at risk
EG0021 affected47 at risk
EG003
Ocular hyperaemia, STUDY EYE ONLY
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Photophobia, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Punctate keratitis, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0001 affected47 at risk
EG0011 affected46 at risk
EG0021 affected47 at risk
EG003
Punctate keratitis, STUDY EYE ONLY
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Trichiasis, FELLOW EYE ONLY
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0011 affected46 at risk
EG0020 affected47 at risk
EG003
Vision blurred, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0001 affected47 at risk
EG0010 affected46 at risk
EG0021 affected47 at risk
EG003
Visual acuity reduced, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Visual acuity reduced, FELLOW EYE ONLY
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0021 affected47 at risk
EG003
Visual acuity reduced, STUDY EYE ONLY
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0001 affected47 at risk
EG0010 affected46 at risk
EG0023 affected47 at risk
EG003
Visual impairment
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Visual impairment, BOTH EYES
Eye disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0021 affected47 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA v12.1
Non-systematic Assessment
EG0001 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v12.1
Non-systematic Assessment
EG0002 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Palatal disorder
Gastrointestinal disorders
MedDRA v12.1
Non-systematic Assessment
EG0001 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Instillation site pain, BOTH EYES
General disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0021 affected47 at risk
EG003
Instillation site pain, STUDY EYE ONLY
General disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Instillation site pruritus, BOTH EYES
General disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Sensation of foreign body, FELLOW EYE ONLY
General disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0021 affected47 at risk
EG003
Temperature intolerance, BOTH EYES
General disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Hypersensitivity, BOTH EYES
Immune system disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Bronchiectasis
Infections and infestations
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0021 affected47 at risk
EG003
Conjunctivitis bacterial, STUDY EYE ONLY
Infections and infestations
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Ear infection
Infections and infestations
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0021 affected47 at risk
EG003
Eyelid infection
Infections and infestations
MedDRA v12.1
Non-systematic Assessment
EG0001 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0021 affected47 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0021 affected47 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Localised infection
Infections and infestations
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Perichondritis
Infections and infestations
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0011 affected46 at risk
EG0020 affected47 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v12.1
Non-systematic Assessment
EG0002 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA v12.1
Non-systematic Assessment
EG0001 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0023 affected47 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0021 affected47 at risk
EG003
Viral pharyngitis
Infections and infestations
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0021 affected47 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Contact lens complication, BOTH EYES
Injury, poisoning and procedural complications
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Corneal abrasion, STUDY EYE ONLY
Injury, poisoning and procedural complications
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0011 affected46 at risk
EG0020 affected47 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Foreign body trauma, FELLOW EYE ONLY
Injury, poisoning and procedural complications
MedDRA v12.1
Non-systematic Assessment
EG0001 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Incision site pain
Injury, poisoning and procedural complications
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Superficial injury of eye, STUDY EYE ONLY
Injury, poisoning and procedural complications
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA v12.1
Non-systematic Assessment
EG0001 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Blood glucose increased
Investigations
MedDRA v12.1
Non-systematic Assessment
EG0001 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Blood triglycerides abnormal
Investigations
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Urine analysis abnormal
Investigations
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA v12.1
Non-systematic Assessment
EG0001 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v12.1
Non-systematic Assessment
EG0002 affected47 at risk
EG0011 affected46 at risk
EG0021 affected47 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0021 affected47 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA v12.1
Non-systematic Assessment
EG0001 affected47 at risk
EG0010 affected46 at risk
EG0021 affected47 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v12.1
Non-systematic Assessment
EG0001 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Amnesia
Nervous system disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Burning sensation, BOTH EYES
Nervous system disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0021 affected47 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0021 affected47 at risk
EG003
Headache
Nervous system disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0012 affected46 at risk
EG0020 affected47 at risk
EG003
Mood altered
Psychiatric disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0021 affected47 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0021 affected47 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v12.1
Non-systematic Assessment
EG0001 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0021 affected47 at risk
EG003
Telangiectasia, STUDY EYE ONLY
Skin and subcutaneous tissue disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0021 affected47 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Impaired work ability, BOTH EYES
Social circumstances
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Injection, BOTH EYES
Surgical and medical procedures
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Hyperaemia
Vascular disorders
MedDRA v12.1
Non-systematic Assessment
EG0001 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
Hypertension
Vascular disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0021 affected47 at risk
EG003
Hypotension
Vascular disorders
MedDRA v12.1
Non-systematic Assessment
EG0000 affected47 at risk
EG0010 affected46 at risk
EG0020 affected47 at risk
EG003
In this study, a variance was made in the planned analysis. At the time of data analysis, results from Stage 1 and 2 were combined for efficacy and safety analyses. Hence, results are presented together for both stages.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D015352
Dry Eye Syndromes
Ancestor Terms
ID
Term
D007766
Lacrimal Apparatus Diseases
D005128
Eye Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C479163
tofacitinib
D016572
Cyclosporine
Ancestor Terms
ID
Term
D003524
Cyclosporins
D010456
Peptides, Cyclic
D047028
Macrocyclic Compounds
D011083
Polycyclic Compounds
D010455
Peptides
D000602
Amino Acids, Peptides, and Proteins
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0051 subjects
FG0060 subjects
2 subjects
FG0051 subjects
FG0063 subjects
2 subjects
FG0050 subjects
FG0061 subjects
58.7
± 14.57
BG00459.9± 11.69
BG00559.8± 14.83
BG00658.9± 14.25
BG00760.0± 13.02
40
BG00334
BG00439
BG00537
BG00638
BG007255
Male
BG00015
BG00111
BG0027
BG00314
BG0049
BG0057
BG0069
BG00772
48
OG00448
OG00544
OG00647
27.1
OG00418.8
OG00518.2
OG00623.4
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
OG004
CP-690,550, 0.005% Twice Daily
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
OG005
CP-690,550, 0.005% Once Daily
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
OG006
Restasis Twice Daily
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Units
Counts
Participants
OG00047
OG00146
OG00247
OG00348
OG00448
OG00544
OG00647
Title
Denominators
Categories
Title
Measurements
OG00025.5
OG00121.7
OG00231.9
OG00322.9
OG00422.9
OG00522.7
OG00636.2
OG003
CP-690,550, 0.003% Twice Daily
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
OG004
CP-690,550, 0.005% Twice Daily
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
OG005
CP-690,550, 0.005% Once Daily
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
OG006
Restasis Twice Daily
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Units
Counts
Participants
OG00045
OG00146
OG00247
OG00348
OG00447
OG00543
OG00644
Title
Denominators
Categories
Ocular discomfort:none
Title
Measurements
OG00055.6
OG00150.0
OG00253.2
OG00352.1
OG00446.8
OG00569.8
OG00634.1
Ocular discomfort:mild
Title
Measurements
OG00033.3
OG00128.3
OG00225.5
OG003
Ocular discomfort:moderate
Title
Measurements
OG00011.1
OG00119.6
OG00219.1
OG003
Ocular discomfort:severe
Title
Measurements
OG0000.0
OG0012.2
OG0022.1
OG003
Ocular discomfort:moderate/severe, duration>=5 min
Title
Measurements
OG0004.4
OG00110.9
OG0028.5
OG003
Burning sensation:none
Title
Measurements
OG00026.7
OG00143.5
OG00223.4
OG003
Burning sensation:mild
Title
Measurements
OG00055.6
OG00139.1
OG00259.6
OG003
Burning sensation:moderate
Title
Measurements
OG00017.8
OG00115.2
OG00214.9
OG003
Burning sensation:severe
Title
Measurements
OG0000.0
OG0012.2
OG0022.1
OG003
Burning sensation:moderate/severe,duration>=5 min
Title
Measurements
OG0000.0
OG0012.2
OG0022.1
OG003
Pain:none
Title
Measurements
OG00082.2
OG00180.4
OG00280.9
OG003
Pain:mild
Title
Measurements
OG00013.3
OG00110.9
OG0028.5
OG003
Pain:moderate
Title
Measurements
OG0004.4
OG0016.5
OG0026.4
OG003
Pain:severe
Title
Measurements
OG0000.0
OG0012.2
OG0024.3
OG003
Pain:moderate/severe, duration >=5 min
Title
Measurements
OG0002.2
OG0010.0
OG0020.0
OG003
Tearing:none
Title
Measurements
OG00055.6
OG00163.0
OG00268.1
OG003
Tearing:mild
Title
Measurements
OG00040.0
OG00126.1
OG00221.3
OG003
Tearing:moderate
Title
Measurements
OG0004.4
OG00110.9
OG00210.6
OG003
Tearing:severe
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Tearing:moderate/severe, duration >= 5 min
Title
Measurements
OG0000.0
OG0012.2
OG0026.4
OG003
Blurred vision:none
Title
Measurements
OG00051.1
OG00154.3
OG00253.2
OG003
Blurred vision:mild
Title
Measurements
OG00040.0
OG00130.4
OG00234.0
OG003
Blurred vision:moderate
Title
Measurements
OG0006.7
OG00115.2
OG00212.8
OG003
Blurred vision:severe
Title
Measurements
OG0002.0
OG0010.0
OG0020.0
OG003
Blurred vision:moderate/severe, duration >=5 min
Title
Measurements
OG0000.0
OG0012.2
OG0024.3
OG003
OG003
CP-690,550, 0.003% Twice Daily
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
OG004
CP-690,550, 0.005% Twice Daily
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
OG005
CP-690,550, 0.005% Once Daily
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
OG006
Restasis Twice Daily
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Units
Counts
Participants
OG00045
OG00145
OG00247
OG00348
OG00446
OG00544
OG00645
Title
Denominators
Categories
Title
Measurements
OG00020.0
OG00117.8
OG00225.5
OG00318.8
OG00426.1
OG00527.3
OG00635.6
CP-690,550, 0.003% Twice Daily
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
OG004
CP-690,550, 0.005% Twice Daily
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
OG005
CP-690,550, 0.005% Once Daily
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
OG006
Restasis Twice Daily
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Units
Counts
Participants
OG00047
OG00146
OG00247
OG00348
OG00448
OG00544
OG00647
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and corresponding upper limit of 80% confidence interval (CI) were not estimable as there were insufficient number of participants, who achieved \>=10 mm Schirmer test score in this reporting group, for the analysis.
OG001NA(NA to NA)Median and corresponding upper limit of 80% CI were not estimable as there were insufficient number of participants, who achieved \>=10 mm Schirmer test score in this reporting group, for the analysis.
OG00259.00(NA to NA)Data is reported in the statistical analysis section because only 80% CI was calculated as it was corresponding to type I error of 10% (1-sided) specified for the study.
OG00358.00(NA to NA)Data is reported in the statistical analysis section because only 80% CI was calculated as it was corresponding to type I error of 10% (1-sided) specified for the study.
OG004NA(NA to NA)Median and corresponding upper limit of 80% CI were not estimable as there were insufficient number of participants, who achieved \>=10 mm Schirmer test score in this reporting group, for the analysis.
OG00557.00(NA to NA)Data is reported in the statistical analysis section because only 80% CI was calculated as it was corresponding to type I error of 10% (1-sided) specified for the study.
OG006NA(NA to NA)Median and corresponding upper limit of 80% CI were not estimable as there were insufficient number of participants, who achieved \>=10 mm Schirmer test score in this reporting group, for the analysis.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG002
Median
59.00
2-Sided
80
57.0
Upper limit of 80% CI was not estimable as there were insufficient number of participants, who achieved >=10 mm Schirmer test score in this reporting group, for the analysis.
No
Superiority or Other
OG003
Median
58.00
2-Sided
80
58.0
Upper limit of 80% CI was not estimable as there were insufficient number of participants, who achieved >=10 mm Schirmer test score in this reporting group, for the analysis.
No
Superiority or Other
OG005
Median
57.00
2-Sided
80
29.0
Upper limit of 80% CI was not estimable as there were insufficient number of participants, who achieved >=10 mm Schirmer test score in this reporting group, for the analysis.
No
Superiority or Other
OG003
CP-690,550, 0.003% Twice Daily
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
OG004
CP-690,550, 0.005% Twice Daily
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
OG005
CP-690,550, 0.005% Once Daily
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
OG006
Restasis Twice Daily
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Units
Counts
Participants
OG00047
OG00146
OG00247
OG00348
OG00448
OG00544
OG00647
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and corresponding 80% CI were not estimable as there were insufficient number of participants, who achieved 100% clearance of corneal staining in this reporting group, for the analysis.
OG001NA(NA to NA)Median and corresponding 80% CI were not estimable as there were insufficient number of participants, who achieved 100% clearance of corneal staining in this reporting group, for the analysis.
OG002NA(NA to NA)Median and corresponding 80% CI were not estimable as there were insufficient number of participants, who achieved 100% clearance of corneal staining in this reporting group, for the analysis.
OG003NA(NA to NA)Median and corresponding 80% CI were not estimable as there were insufficient number of participants, who achieved 100% clearance of corneal staining in this reporting group, for the analysis.
OG004NA(NA to NA)Median and corresponding 80% CI were not estimable as there were insufficient number of participants, who achieved 100% clearance of corneal staining in this reporting group, for the analysis.
OG005NA(NA to NA)Median and corresponding 80% CI were not estimable as there were insufficient number of participants, who achieved 100% clearance of corneal staining in this reporting group, for the analysis.
OG006NA(NA to NA)Median and corresponding 80% CI were not estimable as there were insufficient number of participants, who achieved 100% clearance of corneal staining in this reporting group, for the analysis.
CP-690,550, 0.003% Twice Daily
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
OG004
CP-690,550, 0.005% Twice Daily
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
OG005
CP-690,550, 0.005% Once Daily
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
OG006
Restasis Twice Daily
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Units
Counts
Participants
OG00047
OG00146
OG00247
OG00348
OG00448
OG00544
OG00647
Title
Denominators
Categories
Title
Measurements
OG00015.00(NA to NA)Data is reported in the statistical analysis section because only 80% CI was calculated as it was corresponding to type I error of 10% (1-sided) specified for the study.
OG0018.50(NA to NA)Data is reported in the statistical analysis section because only 80% CI was calculated as it was corresponding to type I error of 10% (1-sided) specified for the study.
OG00215.00(NA to NA)Data is reported in the statistical analysis section because only 80% CI was calculated as it was corresponding to type I error of 10% (1-sided) specified for the study.
OG0039.50(NA to NA)Data is reported in the statistical analysis section because only 80% CI was calculated as it was corresponding to type I error of 10% (1-sided) specified for the study.
OG0049.00(NA to NA)Data is reported in the statistical analysis section because only 80% CI was calculated as it was corresponding to type I error of 10% (1-sided) specified for the study.
OG00515.00(NA to NA)Data is reported in the statistical analysis section because only 80% CI was calculated as it was corresponding to type I error of 10% (1-sided) specified for the study.
OG00616.00(NA to NA)Data is reported in the statistical analysis section because only 80% CI was calculated as it was corresponding to type I error of 10% (1-sided) specified for the study.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Median
15.00
2-Sided
80
9.0
28.0
No
Superiority or Other
OG001
Median
8.50
2-Sided
80
8.0
27.0
No
Superiority or Other
OG002
Median
15.00
2-Sided
80
15.0
27.0
No
Superiority or Other
OG003
Median
9.50
2-Sided
80
8.0
15.0
No
Superiority or Other
OG004
Median
9.00
2-Sided
80
8.0
15.0
No
Superiority or Other
OG005
Median
15.00
2-Sided
80
8.0
43.0
No
Superiority or Other
OG006
Median
16.00
2-Sided
80
15.0
30.0
No
Superiority or Other
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
OG003
CP-690,550, 0.003% Twice Daily
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
OG004
CP-690,550, 0.005% Twice Daily
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
OG005
CP-690,550, 0.005% Once Daily
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
OG006
Restasis Twice Daily
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Units
Counts
Participants
OG00047
OG00146
OG00247
OG00348
OG00448
OG00544
OG00647
Title
Denominators
Categories
Baseline (n=47,46,47,48,48,44,47)
Title
Measurements
OG0004.15± 2.07
OG0014.40± 2.20
OG0024.02± 2.12
OG0033.77± 1.87
OG0044.43± 2.29
OG0054.40± 2.24
OG0064.74± 2.03
Change at Week 1 (n=45,45,47,47,44,42,43)
Title
Measurements
OG0002.06± 4.54
OG0011.68± 4.69
OG0020.80± 3.03
OG003
Change at Week 2 (n=44,46,46,48,45,44,44)
Title
Measurements
OG0002.43± 4.98
OG0011.63± 4.04
OG0022.67± 4.44
OG003
Change at Week 4 (n=44,43,45,48,44,39,43)
Title
Measurements
OG0002.42± 6.64
OG0012.69± 4.56
OG0022.56± 4.76
OG003
Change at Week 6 (n=43,44,43,47,42,41,43)
Title
Measurements
OG0001.86± 3.82
OG0011.41± 3.27
OG0021.59± 3.55
OG003
Change at Week 8 (n=45,46,47,48,47,44,45)
Title
Measurements
OG0001.89± 5.22
OG0012.30± 4.73
OG0022.19± 4.22
OG003
CP-690,550, 0.001% Twice Daily
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
OG003
CP-690,550, 0.003% Twice Daily
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
OG004
CP-690,550, 0.005% Twice Daily
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
OG005
CP-690,550, 0.005% Once Daily
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
OG006
Restasis Twice Daily
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Units
Counts
Participants
OG00047
OG00146
OG00247
OG00348
OG00448
OG00543
OG00647
Title
Denominators
Categories
Baseline (n=47,46,47,48,48,43,47)
Title
Measurements
OG0006.56± 4.69
OG0017.58± 4.44
OG0026.63± 5.05
OG0036.67± 4.01
OG0047.85± 5.35
OG0057.92± 5.13
OG0068.14± 5.75
Change at Week 8 (n=43,43,45,48,41,39,42)
Title
Measurements
OG0002.24± 5.07
OG0010.13± 5.47
OG0022.56± 6.11
OG003
OG003
CP-690,550, 0.003% Twice Daily
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
OG004
CP-690,550, 0.005% Twice Daily
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
OG005
CP-690,550, 0.005% Once Daily
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
OG006
Restasis Twice Daily
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Units
Counts
Participants
OG00045
OG00145
OG00247
OG00348
OG00444
OG00544
OG00644
Title
Denominators
Categories
Week 1
Title
Measurements
OG00020.0
OG0019.1
OG0026.4
OG00314.9
OG00411.6
OG00516.7
OG00630.2
Week 2
Title
Measurements
OG00018.2
OG00120.0
OG00223.9
OG003
Week 4
Title
Measurements
OG00018.2
OG00120.9
OG00217.8
OG003
Week 6
Title
Measurements
OG00020.9
OG0019.1
OG00216.3
OG003
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
OG003
CP-690,550, 0.003% Twice Daily
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
OG004
CP-690,550, 0.005% Twice Daily
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
OG005
CP-690,550, 0.005% Once Daily
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
OG006
Restasis Twice Daily
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Units
Counts
Participants
OG00043
OG00143
OG00245
OG00348
OG00441
OG00539
OG00642
Title
Denominators
Categories
Title
Measurements
OG00032.6
OG00127.9
OG00248.9
OG00331.3
OG00424.4
OG00525.6
OG00638.1
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
OG003
CP-690,550, 0.003% Twice Daily
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
OG004
CP-690,550, 0.005% Twice Daily
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
OG005
CP-690,550, 0.005% Once Daily
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
OG006
Restasis Twice Daily
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Units
Counts
Participants
OG00047
OG00146
OG00247
OG00348
OG00448
OG00544
OG00647
Title
Denominators
Categories
Baseline (n=47,46,47,48,48,44,47)
Title
Measurements
OG0006.64± 3.45
OG0015.63± 1.95
OG0025.83± 2.10
OG0036.73± 2.94
OG0046.21± 2.54
OG0056.36± 2.71
OG0066.85± 3.50
Change at Week 1 (n=45,45,47,47,44,42,44)
Title
Measurements
OG000-1.16± 2.39
OG001-0.89± 2.05
OG002-0.87± 2.25
OG003
Change at Week 2 (n=44,46,46,48,45,44,44)
Title
Measurements
OG000-1.02± 3.16
OG001-1.15± 2.33
OG002-1.00± 2.19
OG003
Change at Week 4 (n=44,43,45,48,44,39,43)
Title
Measurements
OG000-2.48± 2.53
OG001-1.02± 2.58
OG002-1.33± 2.69
OG003
Change at Week 6 (n=43,44,43,48,42,41,43)
Title
Measurements
OG000-2.21± 3.49
OG001-1.39± 2.50
OG002-1.21± 2.42
OG003
Change at Week 8 (n=45,46,47,48,47,44,45)
Title
Measurements
OG000-2.67± 3.44
OG001-1.39± 2.92
OG002-1.28± 2.65
OG003
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
OG003
CP-690,550, 0.003% Twice Daily
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
OG004
CP-690,550, 0.005% Twice Daily
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
OG005
CP-690,550, 0.005% Once Daily
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
OG006
Restasis Twice Daily
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Units
Counts
Participants
OG00045
OG00146
OG00247
OG00348
OG00448
OG00544
OG00644
Title
Denominators
Categories
Week 1
Title
Measurements
OG0002.2
OG0010.0
OG0020.0
OG0030.0
OG0040.0
OG0054.8
OG0060.0
Week 2
Title
Measurements
OG0002.3
OG0014.3
OG0020.0
OG003
Week 4
Title
Measurements
OG0004.5
OG0012.3
OG0024.4
OG003
Week 6
Title
Measurements
OG0004.7
OG0016.8
OG0027.0
OG003
Week 8
Title
Measurements
OG0006.7
OG0016.5
OG0024.3
OG003
CP-690,550, 0.001% Twice Daily
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
OG003
CP-690,550, 0.003% Twice Daily
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
OG004
CP-690,550, 0.005% Twice Daily
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
OG005
CP-690,550, 0.005% Once Daily
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
OG006
Restasis Twice Daily
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Units
Counts
Participants
OG00047
OG00146
OG00247
OG00348
OG00448
OG00543
OG00647
Title
Denominators
Categories
Baseline (n=47,46,47,48,48,43,47)
Title
Measurements
OG0002.77± 2.36
OG0012.17± 1.43
OG0022.21± 1.81
OG0032.38± 2.08
OG0042.17± 1.99
OG0051.91± 1.66
OG0062.43± 2.03
Change at Week 1 (n=45,45,47,47,44,42,43)
Title
Measurements
OG000-0.44± 1.52
OG001-0.38± 1.76
OG002-0.34± 1.75
OG003
Change at Week 2 (n=44,46,46,48,45,43,44)
Title
Measurements
OG000-0.89± 1.53
OG001-0.26± 1.41
OG002-0.37± 1.44
OG003
Change at Week 4 (n=44,43,45,48,44,39,43)
Title
Measurements
OG000-1.11± 1.86
OG001-0.53± 1.65
OG002-0.60± 1.56
OG003
Change at Week 6 (n=43,44,43,48,42,41,43)
Title
Measurements
OG000-0.84± 1.38
OG001-0.73± 1.63
OG002-0.44± 1.74
OG003
Change at Week 8 (n=45,46,47,48,47,43,45)
Title
Measurements
OG000-0.82± 2.01
OG001-0.57± 1.78
OG002-0.62± 1.81
OG003
OG003
CP-690,550, 0.003% Twice Daily
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
OG004
CP-690,550, 0.005% Twice Daily
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
OG005
CP-690,550, 0.005% Once Daily
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
OG006
Restasis Twice Daily
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Units
Counts
Participants
OG00047
OG00146
OG00247
OG00348
OG00448
OG00544
OG00647
Title
Denominators
Categories
Baseline (n=47,46,47,48,48,43,47)
Title
Measurements
OG0003.50± 1.32
OG0013.96± 3.30
OG0024.32± 2.74
OG0034.65± 6.50
OG0044.12± 2.44
OG0053.90± 2.47
OG0063.95± 2.30
Change at Week 1 (n=45,45,47,47,44,42,44)
Title
Measurements
OG0000.17± 1.63
OG0010.60± 2.11
OG0020.21± 2.50
OG003
Change at Week 2 (n=44,46,46,48,45,43,44)
Title
Measurements
OG0000.03± 1.40
OG0011.04± 4.49
OG0020.24± 3.08
OG003
Change at Week 4 (n=44,43,45,48,44,39,43)
Title
Measurements
OG0000.48± 2.14
OG0010.61± 2.95
OG002-0.11± 2.31
OG003
Change at Week 6 (n=43,44,43,48,42,41,43)
Title
Measurements
OG0001.03± 4.65
OG0010.36± 2.77
OG002-0.01± 2.46
OG003
Change at Week 8 (n=45,46,47,48,47,43,45)
Title
Measurements
OG0000.55± 2.19
OG0010.51± 2.93
OG002-0.18± 2.30
OG003
OG003
CP-690,550, 0.003% Twice Daily
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
OG004
CP-690,550, 0.005% Twice Daily
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
OG005
CP-690,550, 0.005% Once Daily
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
OG006
Restasis Twice Daily
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Units
Counts
Participants
OG00047
OG00146
OG00247
OG00348
OG00448
OG00544
OG00647
Title
Denominators
Categories
Baseline (n=47,46,47,48,48,44,47)
Title
Measurements
OG00045.0± 7.66
OG00143.9± 8.09
OG00244.8± 7.69
OG00346.0± 11.22
OG00445.4± 8.41
OG00542.3± 7.01
OG00647.4± 12.51
Change at Week 1 (n=45,45,47,47,44,41,43)
Title
Measurements
OG000-3.7± 7.28
OG001-5.9± 6.44
OG002-4.2± 6.49
OG003
Change at Week 2 (n=44,46,46,48,45,43,44)
Title
Measurements
OG000-6.3± 7.89
OG001-6.0± 5.92
OG002-6.2± 9.00
OG003
Change at Week 4 (n=44,43,45,48,44,41,43)
Title
Measurements
OG000-8.9± 8.44
OG001-7.6± 9.73
OG002-6.8± 8.58
OG003
Change at Week 6 (n=43,44,43,48,42,41,43)
Title
Measurements
OG000-10.1± 9.75
OG001-9.1± 9.35
OG002-8.8± 7.46
OG003
Change at Week 8 (n=45,46,47,48,47,44,44)
Title
Measurements
OG000-9.6± 8.98
OG001-9.9± 9.47
OG002-8.0± 8.81
OG003
OG003
CP-690,550, 0.003% Twice Daily
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
OG004
CP-690,550, 0.005% Twice Daily
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
OG005
CP-690,550, 0.005% Once Daily
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
OG006
Restasis Twice Daily
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Units
Counts
Participants
OG00045
OG00146
OG00247
OG00348
OG00447
OG00544
OG00644
Title
Denominators
Categories
Week 1
Title
Measurements
OG00044.4
OG00153.3
OG00238.3
OG00353.2
OG00456.8
OG00543.9
OG00639.5
Week 2
Title
Measurements
OG00056.8
OG00152.2
OG00245.7
OG003
Week 4
Title
Measurements
OG00068.2
OG00160.5
OG00255.6
OG003
Week 6
Title
Measurements
OG00072.1
OG00168.2
OG00272.1
OG003
Week 8
Title
Measurements
OG00064.4
OG00171.7
OG00259.6
OG003
CP-690,550, 0.003% Twice Daily
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
OG004
CP-690,550, 0.005% Twice Daily
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
OG005
CP-690,550, 0.005% Once Daily
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
OG006
Restasis Twice Daily
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Units
Counts
Participants
OG00047
OG00146
OG00247
OG00348
OG00448
OG00543
OG00647
Title
Denominators
Categories
Baseline (n=47,46,47,48,48,43,47)
Title
Measurements
OG0003.4± 1.58
OG0013.0± 1.63
OG0023.0± 1.16
OG0032.5± 1.65
OG0043.0± 1.65
OG0052.8± 1.20
OG0062.9± 1.60
Change at Week 1 (n=45,46,47,48,47,43,45)
Title
Measurements
OG000-0.7± 1.27
OG001-1.1± 0.99
OG002-0.8± 1.01
OG003
Change at Week 2 (n=44,46,45,48,47,42,44)
Title
Measurements
OG000-0.9± 1.31
OG001-1.2± 1.09
OG002-0.8± 1.20
OG003
Change at Week 4 (n=44,44,45,48,45,41,44)
Title
Measurements
OG000-1.1± 1.60
OG001-1.5± 1.22
OG002-0.9± 1.08
OG003
Change at Week 6 (n=44,44,46,48,43,40,43)
Title
Measurements
OG000-1.5± 1.51
OG001-1.5± 1.08
OG002-0.9± 1.15
OG003
Change at Week 8 (n=46,46,47,48,47,43,46)
Title
Measurements
OG000-1.2± 1.36
OG001-1.6± 1.20
OG002-1.0± 1.19
OG003
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
OG003
CP-690,550, 0.003% Twice Daily
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
OG004
CP-690,550, 0.005% Twice Daily
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
OG005
CP-690,550, 0.005% Once Daily
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
OG006
Restasis Twice Daily
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Units
Counts
Participants
OG00047
OG00146
OG00246
OG00348
OG00448
OG00543
OG00647
Title
Denominators
Categories
Baseline:total (n=47,46,46,48,48,43,47)
Title
Measurements
OG00037.6± 21.46
OG00135.6± 19.71
OG00231.5± 17.95
OG00341.8± 22.04
OG00437.8± 18.76
OG00535.6± 22.45
OG00641.8± 22.93
Baseline:symptoms (n=47,46,46,48,48,43,47)
Title
Measurements
OG00039.7± 22.87
OG00138.8± 21.60
OG00238.6± 20.66
OG003
Baseline:function (n=46,46,45,48,47,43,44)
Title
Measurements
OG00031.8± 21.05
OG00128.8± 20.30
OG00223.5± 19.55
OG003
Baseline:triggers (n=46,41,42,45,42,41,43)
Title
Measurements
OG00046.7± 30.81
OG00149.8± 29.64
OG00242.0± 31.63
OG003
Change at Week 1:total (n=45,45,46,47,44,40,43)
Title
Measurements
OG000-6.8± 14.39
OG001-5.1± 13.61
OG002-6.3± 13.79
OG003
Change at Week 1:symptoms (n=45,45,46,47,44,40,43)
Title
Measurements
OG000-5.9± 16.73
OG001-4.1± 15.85
OG002-8.5± 17.52
OG003
Change at Week 1:function (n=43,45,44,47,43,39,39)
Title
Measurements
OG000-6.1± 15.49
OG001-3.7± 16.32
OG002-4.4± 13.48
OG003
Change at Week 1:triggers (n=43,39,39,43,38,35,39)
Title
Measurements
OG000-7.9± 23.64
OG001-12.0± 24.05
OG002-6.6± 24.74
OG003
Change at Week 2:total (n=44,46,45,48,45,43,44)
Title
Measurements
OG000-8.7± 12.60
OG001-6.2± 12.09
OG002-8.6± 13.66
OG003
Change at Week 2:symptoms (n=44,46,45,48,45,43,44)
Title
Measurements
OG000-9.1± 18.49
OG001-6.2± 13.99
OG002-11.5± 17.79
OG003
Change at Week 2:function (n=42,46,42,48,43,43,41)
Title
Measurements
OG000-8.6± 14.26
OG001-5.8± 13.67
OG002-5.5± 12.92
OG003
Change at Week 2:triggers (n=42,40,40,38,35,39,40)
Title
Measurements
OG000-9.9± 18.38
OG001-7.9± 24.98
OG002-8.8± 24.76
OG003
Change at Week 4:total (n=44,43,44,48,44,41,43)
Title
Measurements
OG000-11.5± 15.88
OG001-7.2± 12.98
OG002-8.1± 15.53
OG003
Change at Week 4:symptoms (n=44,43,44,48,44,41,43)
Title
Measurements
OG000-12.1± 18.19
OG001-8.5± 12.79
OG002-13.4± 20.27
OG003
Change at Week 4:function (n=43,42,42,47,41,41,40)
Title
Measurements
OG000-10.2± 16.42
OG001-4.7± 15.98
OG002-6.3± 16.97
OG003
Change at Week 4:triggers (n=43,36,39,43,36,37,39)
Title
Measurements
OG000-13.5± 26.02
OG001-10.4± 21.90
OG002-5.8± 30.16
OG003
Change at Week 6:total (n=43,44,42,48,42,41,43)
Title
Measurements
OG000-10.5± 14.26
OG001-9.1± 14.19
OG002-7.9± 13.89
OG003
Change at Week 6:symptoms (n=43,44,42,48,42,41,43)
Title
Measurements
OG000-11.2± 18.36
OG001-10.0± 13.76
OG002-12.3± 17.96
OG003
Change at Week 6:function (n=42,44,38,46,40,41,40)
Title
Measurements
OG000-9.1± 18.88
OG001-7.0± 15.30
OG002-5.1± 14.46
OG003
Change at Week 6:triggers (n=40,38,37,41,34,38,39)
Title
Measurements
OG000-13.2± 21.62
OG001-13.0± 24.80
OG002-9.7± 23.61
OG003
Change at Week 8:total (n=45,46,46,48,32,35,39)
Title
Measurements
OG000-11.0± 18.55
OG001-8.5± 15.34
OG002-7.6± 15.22
OG003
Change at Week 8:symptoms (n=45,46,46,48,47,43,44)
Title
Measurements
OG000-13.1± 20.37
OG001-8.9± 16.14
OG002-11.6± 20.52
OG003
Change at Week 8:function (n=44,46,45,48,46,43,41)
Title
Measurements
OG000-9.1± 21.31
OG001-6.4± 16.54
OG002-4.5± 14.82
OG003
Change at Week 8:triggers(n=44,41,42,45,,41,41,41)
Title
Measurements
OG000-12.2± 24.86
OG001-14.2± 24.46
OG002-8.4± 23.62
OG003
OG003
CP-690,550, 0.003% Twice Daily
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
OG004
CP-690,550, 0.005% Twice Daily
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
OG005
CP-690,550, 0.005% Once Daily
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
OG006
Restasis Twice Daily
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Units
Counts
Participants
OG00045
OG00146
OG00246
OG00348
OG00447
OG00543
OG00644
Title
Denominators
Categories
Week 1
Title
Measurements
OG00037.8
OG00137.8
OG00234.8
OG00346.8
OG00445.5
OG00540.0
OG00637.2
Week 2
Title
Measurements
OG00050.0
OG00145.7
OG00240.0
OG003
Week 4
Title
Measurements
OG00047.7
OG00144.2
OG00238.6
OG003
Week 6
Title
Measurements
OG00046.5
OG00152.3
OG00235.7
OG003
Week 8
Title
Measurements
OG00040.0
OG00150.0
OG00241.3
OG003
OG004
CP-690,550, 0.005% Twice Daily
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
OG005
CP-690,550, 0.005% Once Daily
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
OG006
Restasis Twice Daily
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
OG004
CP-690,550, 0.005% Twice Daily
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
OG005
CP-690,550, 0.005% Once Daily
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
OG006
Restasis Twice Daily
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG002
CP-690,550, 0.001% Twice Daily
One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
OG003
CP-690,550, 0.003% Twice Daily
One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
OG004
CP-690,550, 0.005% Twice Daily
One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
OG005
CP-690,550, 0.005% Once Daily
One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
OG006
Restasis Twice Daily
One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
Units
Counts
Participants
OG00047
OG00146
OG00247
OG00348
OG00448
OG00543
OG00647
Title
Denominators
Categories
Baseline: GH (n=46,46,47,48,48,43,47)
Title
Measurements
OG00065.22± 20.74
OG00166.85± 21.12
OG00262.77± 20.10
OG00366.15± 24.99
OG00459.90± 23.49
OG00566.86± 25.43
OG00657.98± 20.92
Baseline: GV (n=47,46,47,48,48,43,47)
Title
Measurements
OG00072.77± 16.38
OG00175.65± 12.59
OG00273.62± 14.51
OG003
Baseline: OP (n=47,46,47,48,48,43,47)
Title
Measurements
OG00059.31± 18.70
OG00159.51± 18.85
OG00261.17± 20.89
OG003
Baseline: NAct (n=47,46,47,48,48,43,47)
Title
Measurements
OG00068.62± 18.49
OG00170.92± 17.53
OG00276.60± 18.60
OG003
Baseline: DA (n=47,46,47,48,48,43,47)
Title
Measurements
OG00073.76± 17.63
OG00177.36± 17.71
OG00281.38± 16.32
OG003
Baseline: SF (n=47,46,47,48,48,43,47)
Title
Measurements
OG00089.10± 14.89
OG00193.21± 10.77
OG00293.88± 11.62
OG003
Baseline: MH (n=47,46,47,48,48,43,47)
Title
Measurements
OG00072.34± 24.55
OG00173.23± 19.88
OG00277.53± 19.71
OG003
Baseline: RD (n=47,46,47,48,48,43,47)
Title
Measurements
OG00068.09± 23.28
OG00172.83± 20.12
OG00276.33± 25.96
OG003
Baseline:dependency (n=47,45,47,47,48,43,47)
Title
Measurements
OG00088.48± 21.46
OG00193.89± 10.42
OG00294.33± 11.54
OG003
Baseline:driving (n=46,44,45,46,41,41,44)
Title
Measurements
OG00073.64± 17.15
OG00176.89± 15.65
OG00277.22± 19.09
OG003
Baseline: CV (n=46,46,47,48,48,43,47)
Title
Measurements
OG00089.67± 21.46
OG00196.20± 9.08
OG00293.62± 13.26
OG003
Baseline: PV (n=47,46,46,48,46,43,47)
Title
Measurements
OG00077.13± 23.21
OG00182.61± 20.32
OG00285.87± 21.51
OG003
Baseline: Overall (n=47,46,47,48,48,43,47)
Title
Measurements
OG00075.62± 14.43
OG00179.30± 10.95
OG00281.08± 12.99
OG003
Change at Week 8: GH (n=42,43,44,48,41,40,41)
Title
Measurements
OG0000.00± 13.53
OG001-2.91± 14.65
OG0020.00± 15.25
OG003
Change at Week 8: GV (n=43,43,44,48,41,40,41)
Title
Measurements
OG0001.86± 16.22
OG0011.86± 12.20
OG0021.36± 7.95
OG003
Change at Week 8: OP (n=43,43,44,48,41,40,41)
Title
Measurements
OG00015.12± 19.59
OG00111.63± 21.89
OG00213.35± 20.95
OG003
Change at Week 8: NAct (n=43,43,44,48,41,40,41)
Title
Measurements
OG0007.17± 17.21
OG0018.62± 15.33
OG0024.17± 12.64
OG003
Change at Week 8: DA (n=43,43,44,48,41,40,41)
Title
Measurements
OG0006.78± 12.50
OG0015.43± 13.22
OG0023.03± 13.46
OG003
Change at Week 8: SF (n=43,43,44,48,41,40,41)
Title
Measurements
OG0003.20± 12.82
OG0012.62± 11.75
OG0022.27± 10.54
OG003
Change at Week 8: MH (n=43,43,44,48,41,40,41)
Title
Measurements
OG00010.61± 19.27
OG0019.59± 17.27
OG0024.55± 13.57
OG003
Change at Week 8: RD (n=43,43,44,48,41,40,41)
Title
Measurements
OG0006.98± 15.74
OG0015.52± 27.59
OG0024.55± 20.37
OG003
Change Week 8:dependency(n=43,42,44,47,41,40,41)
Title
Measurements
OG0007.56± 21.32
OG0011.19± 15.79
OG0021.89± 8.96
OG003
Change at Week 8:driving (n=42,41,42,46,33,38,39)
Title
Measurements
OG0006.15± 14.47
OG0013.46± 16.24
OG0023.27± 13.64
OG003
Change at Week 8: CV (n=42,43,44,48,41,40,41)
Title
Measurements
OG0004.76± 13.79
OG0012.33± 9.15
OG0023.98± 10.71
OG003
Change at Week 8: PV (n=43,43,44,48,39,40,41)
Title
Measurements
OG00011.05± 22.03
OG0014.07± 15.36
OG0021.70± 15.62
OG003
Change at Week 8: Overall (n=43,43,44,48,41,40,41)