A Phase IV Study of Travoprost + Brinzolamide to Treat Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
Double blind, crossover randomized, multicentric study to compare efficacy and tolerability of concomitant administration of travoprost and brinzolamide versus timolol-dorzolamide fixed combination in patients with glaucoma or ocular hypertension

Official Title
-----------------
A Phase IV Study of Travoprost + Brinzolamide to Treat Glaucoma or Ocular Hypertension

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: travoprost 0.004% and brinzolamide 1%
* Drug: fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Diagnosis of bilateral Primary open angle glaucoma or ocular hypertension Intra Ocular Pressure above 19 millimeters mercury at screening visit at 8:00 AM Stable visual field in last 6 months 6 weeks wash out from previous topical medications Exclusion Criteria: Age

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Crossover group ABB<br>3 period, 2 treatment cross-over model: Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for period 1 for 8 weeks. Then participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks) | Drug: travoprost 0.004% and brinzolamide 1%<br>* Group A = concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.)<br>Drug: fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle<br>* group B = fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.).<br>|
| Active Comparator: Crossover group BAA<br>3 period, 2 treatment cross-over model: Participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 1 (8 weeks). Then participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks). | Drug: travoprost 0.004% and brinzolamide 1%<br>* Group A = concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.)<br>Drug: fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle<br>* group B = fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra Ocular Pressure (IOP) | Intra Ocular Pressure, calculated as AUC (area under the curve) of IOP measured from 8.00 a.m. to 8.00 p.m, at different time-points | Baseline, end of each period (week 8, week 16, week 24) |