Travoprost/Brinzolamide Fixed Combination Versus Travatan and Versus AZOPT

Study Overview
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Brief Summary
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The purpose of the study is to compare the IOP lowering efficacy of Travoprost/Brinzolamide dosed daily in the morning or evening, vs TRAVATAN dosed once daily in the evening, and vs. AZOPT dosed BID in patients with open-angle glaucoma or ocular hypertension.

Conditions
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Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Travoprost/Brinzolamide fixed combination
* Drug: Azopt
* Drug: Travatan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 YOA or older Either gender or any race OAG or OHT Currently on stable (at least 4 weeks) IOP lowering medication IOP at screening visit â‰¥ 18mmHg in at least one eye Mean IOP in same eye (at both eligibility 1&2 visits 24 and 36 mmHg at 9AM 21 and 36 mmHg at 11AM and 4PM Able to discontinue use of IOP lowering medication for a minimum wash out period of 5 to 28 days prior to eligibility visit 1 Exclusion Criteria: Related to disease condition being investigated (OAG or OHT) in either eye Severe central visual field loss Angle shaffer grade < 2 C/D ratio >0.8(horizontal or vertical measurement) Related to ocular patient history or current ocular condition in either eye BSCVA worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal) Ocular infection or inflammation or laser surgery within the last 3 months Intraocular surgery or trauma with the last 6 months Any abnormality preventing reliable applanation tonometry History or chronic, recurrently or current severe inflammatory disease History of or current clinically significant or progressive retinal disease History of or current ocular pathology(including severe dry eye) that would affect the conduct of the study Related to systemic or ocular medication in either eye Allergy/hypersensitivity to study medications Unable to discontinue glucocorticoid at least 4 weeks prior to the study or unable to remain off these medications during the study period Use of oral CAIs during the study Recent use (<4 weeks prior to the study) of Aspirin (>1 gram) Less than 30 days stable dosing regimen of medications used on a chronic basis that may affect IOP Therapy with another investigational agent within 30 days prior to the Screening Visit

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Travoprost/Brinzolamide AM, Vehicle PM | Drug: Travoprost/Brinzolamide fixed combination<br>* Eye Drops, suspension once daily<br>|
| Experimental: 2<br>Travoprost/Brinzolamide PM, Vehicle AM | Drug: Travoprost/Brinzolamide fixed combination<br>* Eye Drops, suspension once daily<br>|
| Active Comparator: 3<br>AZOPT AM and PM | Drug: Azopt<br>* Eye Drop Suspension, 1 drop BID<br>|
| Active Comparator: 4<br>TRAVATAN PM, Vehicle AM | Drug: Travatan<br>* Eye Drop Solution, 1 drop BID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean IOP |  | 9, 11, and 16:00 time points at Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean diurnal IOP at Week 12 |  | results pooled across 9,11, and 16:00 time points | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OAG, OH, Open-angle glaucoma or ocular hypertension