Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma

Study Overview
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Brief Summary
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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
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This study was prematurely terminated due to administrative reasons and not due to any safety or efficacy concerns.

Official Title
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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

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: brinzolamide 1%/brimonidine 0.2% fixed combination
* Drug: Placebo
* Drug: travoprost 0.004% ophthalmic solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This was a multicenter, randomized, double-masked, two-arm, placebo-controlled, parallel group study in patients with normal tension glaucoma who were insufficiently controlled on travoprost 0.004% (Travatan) monotherapy.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simbrinza + Travatan<br>Brinzolamide 1%/brimonidine 0.2% fixed combination + travoprost 0.004% ophthalmic solution | Drug: brinzolamide 1%/brimonidine 0.2% fixed combination<br>* One drop applied topically to the affected eye(s) in the morning and evening<br>* Other names: Simbrinza;Drug: travoprost 0.004% ophthalmic solution<br>* One drop applied topically to the affected eye(s) in the evening<br>* Other names: Travatan;|
| Placebo Comparator: Placebo + Travatan<br>Placebo + travoprost 0.004% ophthalmic solution | Drug: Placebo<br>* One drop applied topically to the affected eye(s) in the morning and evening<br>Drug: travoprost 0.004% ophthalmic solution<br>* One drop applied topically to the affected eye(s) in the evening<br>* Other names: Travatan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Diurnal IOP at 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. | Baseline, Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in IOP at Week 6 | IOP was measured by Goldmann applanation tonometry in mmHg. A more negative percent change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis. | Baseline, Week 6 | 
| Mean Diurnal IOP at Week 6 | IOP was measured by Goldmann applanation tonometry in mmHg. Diurnal IOP was defined as the average of the 9:00 and 11:00 time points. One (study eye) contributed to the analysis. | Week 6 | 
| Mean Change From Baseline in IOP for Each Time Point at Week 6 | IOP was measured by Goldmann applanation tonometry in mmHg. A more negative change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis. | Baseline (9:00 am and 11:00 am), Week 6 (9:00 am and 11:00 am) | 
| Percentage Change From Baseline in IOP for Each Time Point at Week 6 | IOP was measured by Goldmann applanation tonometry in mmHg. A more negative percent change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis. | Baseline, Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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travoprost, brinzolamide 1%/brimonidine 0.2%, normal tension glaucoma, intraocular pressure, efficacy, safety