Trial Outcomes & Findings for A Study of 0.15% Brimonidine Tartrate in Patients With Primary Open Angle Glaucoma and Ocular Hypertension (NCT NCT02003534)

Results Overview

IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

376 participants

Primary outcome timeframe

Baseline, Month 3

Results posted on

2014-07-22

Participant Flow

Participant milestones

Participant milestones
Measure	0.15% Brimonidine Tartrate 0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
Overall Study STARTED	376
Overall Study COMPLETED	329
Overall Study NOT COMPLETED	47

Reasons for withdrawal

Reasons for withdrawal
Measure	0.15% Brimonidine Tartrate 0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
Overall Study Lost to Follow-up	47

Baseline Characteristics

A Study of 0.15% Brimonidine Tartrate in Patients With Primary Open Angle Glaucoma and Ocular Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.15% Brimonidine Tartrate n=376 Participants 0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
Age, Continuous	49.8 Years STANDARD_DEVIATION 17.4 • n=5 Participants
Sex: Female, Male Female	161 Participants n=5 Participants
Sex: Female, Male Male	215 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 3

Population: Intent-to-Treat: patients with baseline data and data at the indicated time point

IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).

Outcome measures

Outcome measures
Measure	0.15% Brimonidine Tartrate n=376 Participants 0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye Baseline	25.4 Millimeters of Mercury (mmHg) Standard Deviation 2.3
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye Change from Baseline at Month 3 (N=330)	-6.3 Millimeters of Mercury (mmHg) Standard Deviation 3.5

Adverse Events

0.15% Brimonidine Tartrate

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	0.15% Brimonidine Tartrate n=372 participants at risk 0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
Eye disorders Conjunctiva Hyperemia	6.5% 24/372 The Safety Set included all treated patients and was used to evaluate adverse events (AEs) and serious adverse events (SAEs).

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