Conditions: Glaucoma Ocular Hypertension
Keywords: Glaucoma Ocular Hypertension OAG POAG OHT
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 327
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate Travoprost/Brinzolamide fixed combination (Trav/Brinz) administered twice daily as compared to each of its marketed components (TRAVATAN Z® solution and AZOPT® suspension) and to the unfixed combination of TRAVATAN Z® plus AZOPT® in lowering intraocular pressure (IOP).

Detailed description:
This study was divided into two phases conducted in sequence. Phase I was the Screening/Eligibility Phase, which included a Screening Visit, followed by two Eligibility Visits. Phase II was the randomized, double-masked, 6-week Treatment Phase which included on-therapy visits at Week 2 and Week 6. Travoprost was administered in 1 of 3 concentration levels (A-C), where A=lowest and C=highest.

Arms:
arm 1: Dose Level A / Brinzolamide 1% ophthalmic suspension (fixed combination), 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks arm 2: Dose Level B / Brinzolamide 1% ophthalmic suspension (fixed combination), 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks arm 3: Dose Level C / Brinzolamide 1% ophthalmic suspension (fixed combination), 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks arm 4: Brinzolamide 1% ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks arm 5: Brinzolamide suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks arm 6: Brinzolamide 1% ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks

Interventions: intervention 1: Dose Level A / Brinzolamide 1% ophthalmic suspension intervention 2: Dose Level B / Brinzolamide 1% ophthalmic suspension intervention 3: Dose Level C / Brinzolamide 1% ophthalmic suspension intervention 4: Brinzolamide 1% ophthalmic suspension AZOPT® intervention 5: Travoprost 0.004% ophthalmic solution TRAVATAN Z® intervention 6: Travoprost solution vehicle intervention 7: Brinzolamide suspension vehicle
Intervention descriptions: intervention 1: Fixed combination intervention 2: Fixed combination intervention 3: Fixed combination intervention 4: None intervention 5: None intervention 6: Inactive ingredients used for masking purposes intervention 7: Inactive ingredients used for masking purposes

Protocol document: