Study of Brimonidine and Timolol Ophthalmic Solution With Latanoprost Compared With Latanoprost in Glaucoma Patients
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Allergan
- Enrollment
- 17
- Primary Endpoint
- Change From Baseline in Intraocular Pressure (IOP)
Study Overview
Brief Summary
This study will evaluate the safety and efficacy of patients switched from latanoprost monotherapy to a combination therapy of latanoprost with COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) for chronic angle closure glaucoma.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient has been administering latanoprost eye drops in affected eye(s) for at least 12 weeks prior to study
- •Patient must have at least partially responded to latanoprost and requiring further IOP lowering eye drops
- •Diagnosis of chronic angle-closure glaucoma
- •Patients using COMBIGAN® in the past must not have been discontinued due to adverse events or lack of efficacy.
Exclusion Criteria
- •Known allergy or hypersensitivity to COMBIGAN®
- •Corneal abnormalities that would preclude accurate IOP readings
- •Any other active ocular disease other than glaucoma or ocular hypertension
- •Ocular surgery within the past 3 months.
Arms & Interventions
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.
Intervention: brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution (Drug)
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.
Intervention: latanoprost (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Intraocular Pressure (IOP)
Time Frame: Baseline, Week 12
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.
Secondary Outcomes
- Change From Baseline in IOP(Baseline, Week 2, Week 6)
- Percentage of Responders With an IOP Reduction ≥20% From Baseline(Baseline, Week 12)