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

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

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Catania

Catania, 95123, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 vehicle

Drug

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.).

Primary outcomes

Intra Ocular Pressure (IOP)

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

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

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start: 2007
Primary completion: 2008
First posted: May 9, 2007
Registry last updated: Mar 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed