Trial Outcomes & Findings for Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on COMBIGAN® (Brimonidine 0.2%/Timolol 0.5% Fixed Combination) Therapy in Brazil (NCT NCT01514734)

Results Overview

Intraocular pressure was measured by Goldmann applanation tonometry. Data for the worse eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

9 participants

Primary outcome timeframe

8 weeks

Results posted on

2013-10-21

Participant Flow

Participant milestones

Participant milestones
Measure	AZARGA Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on COMBIGAN® (Brimonidine 0.2%/Timolol 0.5% Fixed Combination) Therapy in Brazil

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AZARGA n=9 Participants Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
Age Continuous	58.56 years STANDARD_DEVIATION 15.83 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment Brazil	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Intraocular pressure was measured by Goldmann applanation tonometry. Data for the worse eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).

Outcome measures

Outcome measures
Measure	AZARGA n=9 Participants Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
Change in Intraocular Pressure (IOP) at 8 Weeks From Baseline (Prior Therapy).	-0.89 millimeters mercury (mmHg) Standard Deviation 4.14

Adverse Events

AZARGA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Doug Hubatsch, Global Brand Leader, Medical Affairs

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER