Trial Outcomes & Findings for Study of Brimonidine and Timolol Ophthalmic Solution With Latanoprost Compared With Latanoprost in Glaucoma Patients (NCT NCT01151904)

Results Overview

IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

17 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2013-02-06

Participant Flow

Due to lack of enrollment, this study was discontinued early.

Participant milestones

Participant milestones
Measure	COMBIGAN® With Latanoprost Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
Overall Study STARTED	17
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Brimonidine and Timolol Ophthalmic Solution With Latanoprost Compared With Latanoprost in Glaucoma Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	COMBIGAN® With Latanoprost n=17 Participants Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
Age, Customized <45 years	0 Participants n=5 Participants
Age, Customized Between 45 and 65 years	7 Participants n=5 Participants
Age, Customized >65 years	10 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Planned analysis population: Intent to Treat: All enrolled patients who received at least 1 dose of study medication, had a valid baseline measurement, and at least one valid post-Day 0 IOP measure. Due to lack of enrollment, analysis was not performed for this outcome measure.

IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 6

Population: Planned analysis population: Intent to Treat: All enrolled patients who received at least 1 dose of study medication, had a valid baseline measurement, and at least one valid post-Day 0 IOP measure. Due to lack of enrollment, analysis was not performed for this outcome measure.

IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Planned analysis population: Intent to Treat: All enrolled patients who received at least 1 dose of study medication, had a valid baseline measurement, and at least one valid post-Day 0 IOP measure. Due to lack of enrollment, analysis was not performed for this outcome measure.

IOP is a measure of the fluid pressure inside the eye. A responder is defined as a patient with a mean IOP reduction of at least 20% in the affected eye(s) from baseline. Due to lack of enrollment, analysis was not performed for this outcome measure.

Outcome measures

Outcome data not reported

Adverse Events

COMBIGAN® With Latanoprost

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	COMBIGAN® With Latanoprost n=17 participants at risk Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
Eye disorders Corneal Erosion	11.8% 2/17
Eye disorders Conjunctival Hyperemia	11.8% 2/17
Nervous system disorders Somnolent	5.9% 1/17

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