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

Alcon Research46 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Glaucoma Ocular Hypertension

Interventions

travoprost 0.004% and brinzolamide 1%DRUG

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.)

fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicleDRUG

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.).

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Catania

Catania, Italy

Outcomes

Primary Outcomes

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

Time frame: Baseline, end of each period (week 8, week 16, week 24)

Data from ClinicalTrials.gov

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