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OpenTrials
Completed

NCT Number: NCT00372827

Study of Brinzolamide and Timolol When Added to Travoprost in Primary Open-angle Glaucoma or Ocular Hypertension

The purpose of the study is to compare the efficacy and safety of Timolol 0.5% solution to Brinzolamide 1% each given twice daily when added to Travoprost 0.004% given each evening.

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Key information

Conditions

Primary Open-Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension Pigment Dispersion Glaucoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mainz Site

Mainz, 55131, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who are treated with any prostaglandin analogue monotherapy (excluding unoprostone) and who have an intraocular pressure between 19 and 32 mmHg at 08:00 hours.

Exclusion criteria

  • Under 18 years

Treatment and study plan

Brinzolamide 1% added to Travoprost 0.004%

Drug

Primary outcomes

  1. Mean diurnal intraocular pressure at month 3

Secondary outcomes

  1. Individual intraocular pressures measured at 08:00, 12:00 and 16:00 at month 3.

  2. Reduction from baseline in mean diurnal intraocular pressure and individual timepoints.

  3. Visual acuity, Slit lamp biomicroscopy and adverse events during 3 months.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Efficacy and Safety of Timolol Maleate 0.5% Compared to Brinzolamide 1% When Added to Travoprost 0.004% in Primary Open-angle Glaucoma or Ocular Hypertension

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 7, 2006
Registry last updated
Nov 21, 2016

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.

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