Trial Outcomes & Findings for An Evaluation of the Fixed Combination Brimonidine Tartrate 0.2%/ Timolol Maleate 0.5% to Latanoprost 0.005% in Glaucoma or Ocular Hypertension Subjects (NCT NCT00811564)

Results Overview

Mean IOP at week 12. IOP is a measurement of the fluid pressure inside the eye.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

148 participants

Primary outcome timeframe

Week 12

Results posted on

2011-09-21

Participant Flow

Participant milestones

Participant milestones
Measure	Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution	Latanoprost 0.005% Ophthalmic Solution Latanoprost 0.005% ophthalmic solution
Overall Study STARTED	73	75
Overall Study COMPLETED	64	73
Overall Study NOT COMPLETED	9	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Evaluation of the Fixed Combination Brimonidine Tartrate 0.2%/ Timolol Maleate 0.5% to Latanoprost 0.005% in Glaucoma or Ocular Hypertension Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate n=73 Participants Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution	Latanoprost 0.005% Ophthalmic Solution n=75 Participants Latanoprost 0.005% ophthalmic solution	Total n=148 Participants Total of all reporting groups
Age Continuous	65 years n=99 Participants	65 years n=107 Participants	65 years n=206 Participants
Sex: Female, Male Female	42 Participants n=99 Participants	44 Participants n=107 Participants	86 Participants n=206 Participants
Sex: Female, Male Male	31 Participants n=99 Participants	31 Participants n=107 Participants	62 Participants n=206 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Intent-to-treat, which included all patients who started the study (randomized).

Mean IOP at week 12. IOP is a measurement of the fluid pressure inside the eye.

Outcome measures

Outcome measures
Measure	Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate n=73 Participants Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution	Latanoprost 0.005% Ophthalmic Solution n=75 Participants Latanoprost 0.005% ophthalmic solution
Intraocular Pressure (IOP) at Week 12	17.75 Millimeters of mercury (mm Hg) Standard Deviation 2.878	17.90 Millimeters of mercury (mm Hg) Standard Deviation 3.943

Adverse Events

Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Latanoprost 0.005% Ophthalmic Solution

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate n=73 participants at risk Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution	Latanoprost 0.005% Ophthalmic Solution n=75 participants at risk Latanoprost 0.005% ophthalmic solution
Blood and lymphatic system disorders Anemia	0.00% 0/73 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	1.3% 1/75 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.

Other adverse events

Other adverse events
Measure	Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate n=73 participants at risk Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution	Latanoprost 0.005% Ophthalmic Solution n=75 participants at risk Latanoprost 0.005% ophthalmic solution
Eye disorders Eye irritation	5.5% 4/73 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	0.00% 0/75 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
Eye disorders Pain eye	5.5% 4/73 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	0.00% 0/75 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.

Additional Information

Vice President Medical Affairs

Allergan, Inc.

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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 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
Publication restrictions are in place

Restriction type: OTHER