A Phase 3 Prospective, Randomized, Double-Masked, 12-Week... | NCT00716859

NCT00716859

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Timolol	Active Comparator		Drug: Timolol
latanoprost	Experimental		Drug: latanoprost

Name	Type	Description	Arm Group Labels	Other Names
Timolol	Drug	Timolol 0.5% dosed twice-daily	Timolol
latanoprost

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF)	Calculated as Baseline IOP minus Week 12 IOP, LOCF. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were less than or equal to (≤) 2 millimeters of mercury (mmHg) of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.	Baseline, Week 12

Secondary Outcomes

Measure	Description	Time Frame
Reduction From Baseline in Mean IOP at Week 1	Calculated as Baseline IOP minus Week 1 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Pembroke Pines	Florida	33028	United States
Pfizer Investigational Site

References Module

Label	URL
To obtain contact information for a study center near you, click here.	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Timolol	Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
FG001	Latanoprost

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Timolol	Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
BG001	Latanoprost	Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

Participants

Title

Denominators

Categories

Title	Measurements
	OG0005.72± 0.81 OG0017.18± 0.81

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 OG001	Null hypothesis: latanoprost inferior to timolol (0.5 percent [%] optionally 0.25% for participants younger than 3 years). Power calculation: assuming common standard deviation (7 mmHg), 110 participants have 84% power to demonstrate latanoprost not inferior to timolol within 3 mmHg margin, assuming latanoprost has 1 mmHg reduction more than timolol in mean change from baseline IOP.					Mean Difference (Net)	1.46			2-Sided	95	-0.81	3.74					Non-Inferiority or Equivalence (legacy)	If lower limit of 95% Confidence Interval (CI) for treatment difference is above non-inferiority margin, then non-inferiority concluded. If lower limit of 95% CI for treatment difference is above non-inferiority margin and above zero, then superiority concluded. The difference and 95% CI of the difference in IOP reduction (Week 12) was computed from an analysis of covariance (ANCOVA) model with treatment and baseline diagnosis as factors and baseline IOP as covariate.

Secondary

Reduction From Baseline in Mean IOP at Week 1

Calculated as Baseline IOP minus Week 1 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline, Week 1

ID	Title	Description
OG000	Timolol	Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
OG001	Latanoprost	Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.

Units	Counts
Participants

Secondary

Reduction From Baseline in Mean IOP at Week 4

Calculated as Baseline IOP minus Week 4 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.

Evaluable participants in PP

Posted

Least Squares Mean

Standard Error

mmHg

Baseline, Week 4

ID	Title	Description
OG000	Timolol	Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
OG001	Latanoprost	Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.

Units	Counts
Participants

Secondary

Reduction From Baseline in Mean IOP at Week 12 (Observed)

Calculated as Baseline IOP minus Week 12 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.

Evaluable participants in PP

Posted

Least Squares Mean

Standard Error

mmHg

Baseline, Week 12

ID	Title	Description
OG000	Timolol	Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
OG001	Latanoprost	Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.

Units	Counts
Participants

Secondary

Mean IOP at Baseline

IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.

Posted

Mean

Standard Deviation

mmHg

Baseline

ID	Title	Description
OG000	Timolol	Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
OG001	Latanoprost	Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.

Units	Counts
Participants	OG000

Secondary

Mean IOP at Week 1

Posted

Mean

Standard Deviation

mmHg

Week 1

ID	Title	Description
OG000	Timolol	Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
OG001	Latanoprost	Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.

Units	Counts
Participants	OG000

Secondary

Mean IOP at Week 4

Evaluable participants in PP

Posted

Mean

Standard Deviation

mmHg

Week 4

ID	Title	Description
OG000	Timolol	Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
OG001	Latanoprost	Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.

Units	Counts
Participants	OG000

Secondary

Mean IOP at Week 12

Evaluable participants in PP

Posted

Mean

Standard Deviation

mmHg

Week 12

ID	Title	Description
OG000	Timolol	Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
OG001	Latanoprost	Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Greater Than or Equal to (≥) 15% IOP Reduction From Baseline at Both Weeks 4 and 12

Participants with ≥15% IOP reduction from baseline at both Week 4 and Week 12. Calculated as (post baseline IOP minus baseline IOP) divided by IOP, multiplied by 100%. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.

Evaluable participants in PP

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline, Week 4, and Week 12

ID	Title	Description
OG000	Timolol	Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
OG001	Latanoprost	Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.

Units	Counts

Secondary

Percentage of Participants Discontinuing Therapy Due to a Drug-related Adverse Experience

An investigator's causality assessment was the determination of whether there existed a reasonable possibility that the investigational product caused or contributed to an adverse event (AE). If the investigator did not know whether or not investigational product caused the event, then the event was handled as "related to investigational product" for reporting purposes.

Intent to treat (ITT) population: all participants who were randomized into the study and received at least 1 dose of study medication.

Posted

Number

Percentage of particpants

Baseline through Week 12

ID	Title	Description
OG000	Timolol	Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
OG001	Latanoprost	Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.

Units	Counts
Participants

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	Timolol	Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .			7	69	20	69
EG001	Latanoprost	Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.			2	68	12	68

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Developmental glaucoma, both eyes	Congenital, familial and genetic disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected69 at risk EG0010 affected68 at risk
Angle closure glaucoma, both eyes	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected69 at risk EG0010 affected68 at risk
Glaucoma, both eyes	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected69 at risk EG0010 affected68 at risk
Eye haemorrhage, study eye	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected69 at risk EG0010 affected68 at risk
Lens dislocation, study eye	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected69 at risk EG0011 affected68 at risk
Corneal perforation, fellow eye	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected69 at risk EG0010 affected68 at risk
Acute tonsillitis	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0001 affected69 at risk EG0010 affected68 at risk
Bronchitis	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0001 affected69 at risk EG0010 affected68 at risk
Bronchopneumonia	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0000 affected69 at risk EG0011 affected68 at risk
Gastroenteritis	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0000 affected69 at risk EG0011 affected68 at risk
Pneumonia	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0001 affected69 at risk EG0010 affected68 at risk
Pneumonia viral	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0000 affected69 at risk EG0011 affected68 at risk
Epilepsy	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected69 at risk EG0010 affected68 at risk
Trabeculectomy, both eyes	Surgical and medical procedures	MedDRA v12.1	Systematic Assessment	EG0001 affected69 at risk EG0010 affected68 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Conjunctival disorder, both eyes	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected69 at risk EG0010 affected68 at risk
Conjunctival hyperaemia, both eyes	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0003 affected69 at risk EG0011 affected68 at risk
Conjunctival hyperaemia, study eye	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0003 affected69 at risk EG0012 affected68 at risk
Visual acuity reduced, study eye	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected69 at risk EG0010 affected68 at risk
Pyrexia	General disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected69 at risk EG0012 affected68 at risk
Influenza	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0004 affected69 at risk EG0010 affected68 at risk
Nasopharyngitis	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0005 affected69 at risk EG0014 affected68 at risk
Rhinitis	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0001 affected69 at risk EG0012 affected68 at risk
Viral infection	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0002 affected69 at risk EG0011 affected68 at risk
Headache	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0004 affected69 at risk EG0012 affected68 at risk

ID	Term
D005901	Glaucoma

ID	Term
D013999	Timolol
D000077338	Latanoprost

Ancestor Terms

ID	Term
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D020005	Propanols
D000588	Amines
D013830	Thiadiazoles
D013844	Thiazoles
D013457	Sulfur Compounds
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D009025	Morpholines
D010078	Oxazines
D011461	Prostaglandins F, Synthetic
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins
D015777	Eicosanoids
D005231	Fatty Acids, Unsaturated
D005227	Fatty Acids
D008055	Lipids
D012898	Autacoids
D018836	Inflammation Mediators
D001685	Biological Factors

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases