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This study will evaluate the safety and efficacy of a new artificial tear for the treatment of dry eye that may occur after LASIK surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carboxymethylcellulose and Glycerin based artificial tear | Experimental | Carboxymethylcellulose and Glycerin based artificial tear |
|
| Carboxymethylcellulose based artificial tear | Active Comparator | Carboxymethylcellulose based artificial tear |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboxymethylcellulose and Glycerin based artificial tear | Drug | As directed by Investigator at the end of each study visit: 1 to 2 drops in each eye, 1 to 2 times a day up to every hour while awake |
| Measure | Description | Time Frame |
|---|---|---|
| Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90 | Measured on 12 domains (categories); a 5-point scale for each domain (0 = best, no dry eye symptoms, 4 = worst, constant dry eye symptoms). Sum of the domain scores is normalized (standardized) to a severity scale of 0-100 (0 = no symptoms (best score), 100 = maximum severity (worst score)). | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | A questionnaire was administered to all patients to evaluate the acceptability of the Artificial Tears (referred to as AT). Percentage of patients responding either "Agree" or "Strongly Agree" at day 90 was tabulated. The potential response categories included "Strongly Agree", "Agree", "Neither Agree Nor Disagree", "Disagree" and "Strongly Disagree". |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60 | Number of patients prescribed to each dosing regimen at Day 14 and Day 60. At each visit from Day 14 (the first post-operative visit) to Day 60, patients were prescribed to 1 to 4 dosing regimens based on the investigator's clinical evaluation. Dosing schedule options were: At least every 2 hours while awake, 6 to 8 times per day, 3 to 5 times per day, at 1 to 2 times per day. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego | California | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Carboxymethylcellulose and Glycerin Based Artificial Tear | Carboxymethylcellulose and Glycerin based artificial tear |
| FG001 | Carboxymethylcellulose Based Artificial Tear | Carboxymethylcellulose based artificial tear |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Carboxymethylcellulose and Glycerin Based Artificial Tear | Carboxymethylcellulose and Glycerin based artificial tear |
| BG001 | Carboxymethylcellulose Based Artificial Tear | Carboxymethylcellulose based artificial tear |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90 | Measured on 12 domains (categories); a 5-point scale for each domain (0 = best, no dry eye symptoms, 4 = worst, constant dry eye symptoms). Sum of the domain scores is normalized (standardized) to a severity scale of 0-100 (0 = no symptoms (best score), 100 = maximum severity (worst score)). | Intent to Treat population defined as all patients who started the study and were randomized | Posted | Mean | Standard Deviation | Scores on a Scale | Day 90 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Carboxymethylcellulose and Glycerin Based Artificial Tear | Carboxymethylcellulose and Glycerin based artificial tear |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Punctate Keratitis | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan, Inc. | (714)246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002266 | Carboxymethylcellulose Sodium |
| ID | Term |
|---|---|
| D008747 | Methylcellulose |
| D002482 | Cellulose |
| D005936 | Glucans |
| D011134 | Polysaccharides |
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| Carboxymethylcellulose | Drug | As directed by Investigator at the end of each study visit: 1 to 2 drops in each eye, 1 to 2 times a day up to every hour while awake |
|
|
| Day 90 |
| Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | A patient acceptability - sensory questionnaire was administered to all patients to evaluate the acceptability of the Artificial Tears (AT). Percentage of patients responding either "Agree" or "Strongly Agree" at day 90 was tabulated. The potential response categories included "Strongly Agree", "Agree", "Neither Agree Nor Disagree", "Disagree" and "Strongly Disagree". | Day 90 |
| Best Corrected Visual Acuity (BCVA) Status at Day 90 | BCVA status at Day 90 reported as the number of patients whose scores were either "Better", "No Change", or "Worse" than their scores at baseline. The status was tabulated as number of lines read correctly at Day 90 minus the number of lines read correctly at baseline. "Better" equals increase of 2 lines or more; "No Change" equals change between -2 to +2 lines; "Worse" equals decrease of 2 lines or more. BCVA is measured using a special eye chart a nd is reported as the number of lines (5 letters per line) read correctly. | Day 90 |
| Change From Baseline of the Worse Eye in Corneal Topography as Measured by Pentacam at Day 90 | Change from Baseline in corneal topography of the worse eye as measured using a Pentacam system which calculates a number. Corneal topography is a non-invasive medical imaging technique for mapping the surface of the eye. The Pentacam system measures the pupil and anterior segment (the front part of the eye) which provides a range from 10 (best) to 60 (worst). A negative number change from baseline indicates an improvement. | Baseline, Day 90 |
| Change From Baseline of the Worse Eye in Corneal Topography Measured by Humphrey Atlas at Day 90 | Change from Baseline in corneal topography of the worse eye as measured by a Humphrey Atlas system which calculates a number. Corneal topography is anon-invasive medical imaging technique for mapping the surface curvature of the cornea (the outer structure of the eye). The higher the number the more irregular the cornea. A Humphrey Atlas system detects irregular conditions in the cornea with a range from 0 = best to 2.5 = worst. A negative number change from baseline indicates an improvement. | Baseline, Day 90 |
| Change From Baseline of Total Higher Order Aberration (HOA) of the Worse Eye at Day 90 | Change from Baseline in total HOA of the worse eye. The total HOA number is measured using a machine that calculates and detects changes in the cornea which could occur post Lasik surgery. A negative number change from baseline indicates an improvement. | Baseline, Day 90 |
| Change From Baseline of the Worse Eye in Schirmer's Test at Day 90 | Change from baseline in Schirmer's Test results at Day 90 in the worse eye. The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears). The smaller the number, the more severe the dry eye. | Baseline, Day 90 |
| Change From Baseline of the Worse Eye in Corneal Staining With Fluorescein at Day 90 | Change from Baseline in corneal staining of the worse eye at Day 90. Sum of corneal staining over 5 zones; each zone was measured on a modified Oxford Scheme (0 = no staining and 5 = severe staining), for a minimum score of 0 and a maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative change from baseline represents a decrease in corneal staining (improvement). | Baseline, Day 90 |
| Change From Baseline of the Worse Eye in Conjunctival Staining With Lissamine Green at Day 90 | Change from Baseline in conjunctival staining of the worse eye using Lissamine Green staining procedure. Sum of conjunctival staining over 6 zones; each zone was measured on a modified Oxford Scheme (0 = no staining and 5 = severe staining), with a minimum score of 0 and a maximum score of 30. The higher the grade score, the worse dry eye condition. A negative number change from baseline represents a decrease in corneal staining (improvement). | Baseline, Day 90 |
| Change From Baseline of the Worse Eye in Tear Break-Up Time (TBUT) at Day 90 | Change from Baseline in TBUT of the worse eye at Day 90. TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement). | Baseline, Day 90 |
| Change From Baseline in Study Product Usage at Day 90 | Change from baseline in the study product usage (average number of uses per day) at Day 90. A negative number change from baseline indicates a reduction in eye drop usage (improvement). | Baseline, Day 90 |
| Day 14, Day 60 |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Carboxymethylcellulose based artificial tear |
|
|
| Secondary | Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | A questionnaire was administered to all patients to evaluate the acceptability of the Artificial Tears (referred to as AT). Percentage of patients responding either "Agree" or "Strongly Agree" at day 90 was tabulated. The potential response categories included "Strongly Agree", "Agree", "Neither Agree Nor Disagree", "Disagree" and "Strongly Disagree". | Intent to Treat includes all patients who started the study are were randomized. Only those patients who answered the particular question on Day 90 were analyzed. This is indicated in parenthesis as (number of patients in the first arm who answered that specific question/Number of patients in the second arm who answered that specific question). | Posted | Number | Percentage of Patients | Day 90 |
|
|
|
| Secondary | Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 | A patient acceptability - sensory questionnaire was administered to all patients to evaluate the acceptability of the Artificial Tears (AT). Percentage of patients responding either "Agree" or "Strongly Agree" at day 90 was tabulated. The potential response categories included "Strongly Agree", "Agree", "Neither Agree Nor Disagree", "Disagree" and "Strongly Disagree". | Intent to Treat includes all patients who started the study and were randomized. Only those patients who answered the particular question on Day 90 were analyzed. This is indicated in parenthesis as (number of patients in the first arm who answered that specific question/Number of patients in the second arm who answered that specific question). | Posted | Number | Percentage of Patients | Day 90 |
|
|
|
| Secondary | Best Corrected Visual Acuity (BCVA) Status at Day 90 | BCVA status at Day 90 reported as the number of patients whose scores were either "Better", "No Change", or "Worse" than their scores at baseline. The status was tabulated as number of lines read correctly at Day 90 minus the number of lines read correctly at baseline. "Better" equals increase of 2 lines or more; "No Change" equals change between -2 to +2 lines; "Worse" equals decrease of 2 lines or more. BCVA is measured using a special eye chart a nd is reported as the number of lines (5 letters per line) read correctly. | Intent to Treat includes all patients who started the study and were randomized. One patient's status in the first arm was not available at Day 90 and was not evaluated for this outcome measure therefore only 113 patients were analyzed for this outcome measure. | Posted | Number | Number of Patients | Day 90 |
|
|
|
| Secondary | Change From Baseline of the Worse Eye in Corneal Topography as Measured by Pentacam at Day 90 | Change from Baseline in corneal topography of the worse eye as measured using a Pentacam system which calculates a number. Corneal topography is a non-invasive medical imaging technique for mapping the surface of the eye. The Pentacam system measures the pupil and anterior segment (the front part of the eye) which provides a range from 10 (best) to 60 (worst). A negative number change from baseline indicates an improvement. | Intent-to-Treat population defined as all patients who started the study and were randomized | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Day 90 |
|
|
|
| Secondary | Change From Baseline of the Worse Eye in Corneal Topography Measured by Humphrey Atlas at Day 90 | Change from Baseline in corneal topography of the worse eye as measured by a Humphrey Atlas system which calculates a number. Corneal topography is anon-invasive medical imaging technique for mapping the surface curvature of the cornea (the outer structure of the eye). The higher the number the more irregular the cornea. A Humphrey Atlas system detects irregular conditions in the cornea with a range from 0 = best to 2.5 = worst. A negative number change from baseline indicates an improvement. | Intent-to-Treat population defined as all patients who started the study and were randomized | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Day 90 |
|
|
|
| Secondary | Change From Baseline of Total Higher Order Aberration (HOA) of the Worse Eye at Day 90 | Change from Baseline in total HOA of the worse eye. The total HOA number is measured using a machine that calculates and detects changes in the cornea which could occur post Lasik surgery. A negative number change from baseline indicates an improvement. | Intent-to-Treat population defined as all patients who started the study and were randomized | Posted | Mean | Standard Deviation | Microns | Baseline, Day 90 |
|
|
|
| Secondary | Change From Baseline of the Worse Eye in Schirmer's Test at Day 90 | Change from baseline in Schirmer's Test results at Day 90 in the worse eye. The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears). The smaller the number, the more severe the dry eye. | Intent-to-Treat population defined as all patients who started the study and were randomized | Posted | Mean | Standard Deviation | Millimeters of Tears | Baseline, Day 90 |
|
|
|
| Secondary | Change From Baseline of the Worse Eye in Corneal Staining With Fluorescein at Day 90 | Change from Baseline in corneal staining of the worse eye at Day 90. Sum of corneal staining over 5 zones; each zone was measured on a modified Oxford Scheme (0 = no staining and 5 = severe staining), for a minimum score of 0 and a maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative change from baseline represents a decrease in corneal staining (improvement). | Intent to Treat population defined as all patients who started the study and were randomized | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Day 90 |
|
|
|
| Secondary | Change From Baseline of the Worse Eye in Conjunctival Staining With Lissamine Green at Day 90 | Change from Baseline in conjunctival staining of the worse eye using Lissamine Green staining procedure. Sum of conjunctival staining over 6 zones; each zone was measured on a modified Oxford Scheme (0 = no staining and 5 = severe staining), with a minimum score of 0 and a maximum score of 30. The higher the grade score, the worse dry eye condition. A negative number change from baseline represents a decrease in corneal staining (improvement). | Intent-to-Treat population defined as all patients who started the study and were randomized | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Day 90 |
|
|
|
| Secondary | Change From Baseline of the Worse Eye in Tear Break-Up Time (TBUT) at Day 90 | Change from Baseline in TBUT of the worse eye at Day 90. TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement). | Intent-to-Treat population defined as all patients who started the study and were randomized | Posted | Mean | Standard Deviation | Number of seconds | Baseline, Day 90 |
|
|
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| Other Pre-specified | Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60 | Number of patients prescribed to each dosing regimen at Day 14 and Day 60. At each visit from Day 14 (the first post-operative visit) to Day 60, patients were prescribed to 1 to 4 dosing regimens based on the investigator's clinical evaluation. Dosing schedule options were: At least every 2 hours while awake, 6 to 8 times per day, 3 to 5 times per day, at 1 to 2 times per day. | Intent to Treat includes all patients that started the study and were randomized. Only those patients who were prescribed a dosing regimen at Day 14 to Day 60 visits were analyzed. The is indicated in parenthesis as (number of patients in arm 1 who were prescribed/number of patients in arm 2 who were prescribed). | Posted | Number | Number of patients | Day 14, Day 60 |
|
|
|
| Secondary | Change From Baseline in Study Product Usage at Day 90 | Change from baseline in the study product usage (average number of uses per day) at Day 90. A negative number change from baseline indicates a reduction in eye drop usage (improvement). | Intent-to-Treat includes all patients that started the study and were randomized. Only those patients who reported actual eye drop use at Baseline and on Day 90 were analyzed. This is indicated in parenthesis as (number of patients in arm 1 who reported eye drop use/number of patients in arm 2 who reported eye drop use). | Posted | Mean | Standard Deviation | Number of study product uses per day | Baseline, Day 90 |
|
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|
| 0 |
| 114 |
| 88 |
| 114 |
| EG001 | Carboxymethylcellulose Based Artificial Tear | Carboxymethylcellulose based artificial tear | 0 | 114 | 82 | 114 |
| Halo Vision | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Dry Eye | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Glare | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Conjucntival Haemorrhage | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Eye Operation Complications | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Foreign Body Sensation in Eyes | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Photophobia | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Ocular discomfort | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D002241 |
| Carbohydrates |
| AT were soothing to eyes (111/110) |
|
| AT protected eyes from dryness (112/109) |
|
| AT protected eyes from low humidity (112/110) |
|
| Vision was normal few min.after AT use(112/110) |
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| Few min. after use, AT gave clear vision(111/110) |
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| AT helped eyes heal from surgery (112/110) |
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| AT helped eyes feel same as pre-LASIK (111/110) |
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| It's good to use AT after surgery(111/109) |
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| AT did not cause my eyes to get crusty (112/108) |
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| AT were easy to use (112/109) |
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| AT were convenient to use (112/109) |
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| AT were important to a good outcome (111/109) |
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| AT were helpful to achieve comfort (112/109) |
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| AT were helpful to achieve good vision (112/109) |
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| I no longer feel I need to use AT (111/108) |
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| Worse |
|
| Day 14: 3-5 times a day (113/110) |
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| Day 14: 1-2 times a day (113/110) |
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| Day 60: at least every 2 hrs (109/107) |
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| Day 60: 6-8 times a day (109/107) |
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| Day 60: 3-5 times a day (109/107) |
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| Day 60: 1-2 times a day (109/107) |
|