A 6-week, Double Masked, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Twice-daily Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as an Adjunctive Therapy to Travoprost 0.004% in Reducing Intraocular Pressure in Patients With Normal Tension Glaucoma
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Mean Change From Baseline in Diurnal IOP at Week 6
Study Overview
Brief Summary
The purpose of this study was to determine the incremental intraocular pressure (IOP) lowering that is achieved when Simbrinza is used adjunctively to Travatan in patients with normal tension glaucoma that may benefit from further IOP lowering.
Detailed Description
This study was prematurely terminated due to administrative reasons and not due to any safety or efficacy concerns.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Sign written informed consent
- •Diagnosed with normal tension glaucoma
- •Intraocular pressure measurements in at least 1 eye as specified in the protocol
- •Willing and able to attend all study visits
Exclusion Criteria
- •History of hypersensitivity to any of the study drugs
- •Use of medications prohibited by the protocol
- •Pregnant or nursing
- •Of child-bearing potential unless using contraception, as specified in the protocol
- •Any form of glaucoma other than open angle glaucoma in either eye
- •Chronic, recurrent or severe inflammatory eye disease
- •Ocular trauma or surgery within the past 6 months in either eye; ocular infection or laser surgery within the past 3 months in either eye (all from screening)
- •Conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study.
Arms & Interventions
Simbrinza + Travatan
Brinzolamide 1%/brimonidine 0.2% fixed combination + travoprost 0.004% ophthalmic solution
Intervention: brinzolamide 1%/brimonidine 0.2% fixed combination (Drug)
Simbrinza + Travatan
Brinzolamide 1%/brimonidine 0.2% fixed combination + travoprost 0.004% ophthalmic solution
Intervention: travoprost 0.004% ophthalmic solution (Drug)
Placebo + Travatan
Placebo + travoprost 0.004% ophthalmic solution
Intervention: Placebo (Drug)
Placebo + Travatan
Placebo + travoprost 0.004% ophthalmic solution
Intervention: travoprost 0.004% ophthalmic solution (Drug)
Outcomes
Primary Outcomes
Mean Change From Baseline in Diurnal IOP at Week 6
Time Frame: Baseline, Week 6
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry in millimeters mercury (mmHg). Diurnal IOP was defined as the average of the 9:00 am and 11:00 am time points. A more negative change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis.
Secondary Outcomes
- Mean Change From Baseline in IOP for Each Time Point at Week 6(Baseline (9:00 am and 11:00 am), Week 6 (9:00 am and 11:00 am))
- Percent Change From Baseline in IOP at Week 6(Baseline, Week 6)
- Mean Diurnal IOP at Week 6(Week 6)
- Percentage Change From Baseline in IOP for Each Time Point at Week 6(Baseline, Week 6)