Trial Outcomes & Findings for Safety and Efficacy of Brimonidine Tartrate/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension (NCT NCT01229462)

Results Overview

Intraocular pressure (IOP) was measured in the study eye at baseline and Week 4. IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

238 participants

Primary outcome timeframe

Baseline, Week 4

Results posted on

2012-09-14

Participant Flow

Participant milestones

Participant milestones
Measure	Combigan® One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.	Alphagan® and Timolol Concurrent One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Overall Study STARTED	120	118
Overall Study COMPLETED	115	109
Overall Study NOT COMPLETED	5	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Brimonidine Tartrate/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combigan® n=120 Participants One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.	Alphagan® and Timolol Concurrent n=118 Participants One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.	Total n=238 Participants Total of all reporting groups
Age Continuous	46.2 Years STANDARD_DEVIATION 15.18 • n=5 Participants	48.2 Years STANDARD_DEVIATION 15.57 • n=7 Participants	47.2 Years STANDARD_DEVIATION 15.38 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	55 Participants n=7 Participants	103 Participants n=5 Participants
Sex: Female, Male Male	72 Participants n=5 Participants	63 Participants n=7 Participants	135 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 4

Population: Intent-to-treat population consisted of all randomized participants.

Intraocular pressure (IOP) was measured in the study eye at baseline and Week 4. IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).

Outcome measures

Outcome measures
Measure	Combigan® n=120 Participants One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.	Alphagan® and Timolol Concurrent n=118 Participants One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4 Baseline	25.07 mm Hg Standard Deviation 3.737	24.53 mm Hg Standard Deviation 2.926
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4 Change from baseline at Week 4	-6.21 mm Hg Standard Deviation 3.550	-5.70 mm Hg Standard Deviation 3.469

Adverse Events

Combigan®

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Alphagan® and Timolol Concurrent

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Combigan® n=120 participants at risk One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.	Alphagan® and Timolol Concurrent n=116 participants at risk One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Ear and labyrinth disorders Sudden hearing loss	0.83% 1/120 Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.	0.00% 0/116 Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
Nervous system disorders VIth nerve paralysis	0.00% 0/120 Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.	0.86% 1/116 Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.

Other adverse events

Adverse event data not reported

Additional Information

Therapeutic Area Head,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place