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OpenTrials
Completed

NCT Number: NCT00293800

A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

The purpose of the study is to evaluate the safety and effectiveness of an investigational glaucoma therapy in patients with open-angle glaucoma or ocular hypertension.

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Key information

Conditions

Open-angle Glaucoma Cardiovascular Diseases Eye Diseases Glaucoma Glaucoma, Open-Angle Hypertension Ocular Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years or older.
  • Diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension.
  • Mean intraocular pressure (IOP) in at least one eye greater than 21 mmHg and less than or equal to 36 mmHg at screening visit.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Pregnant
  • History of chronic or recurrent severe inflammatory eye disease.
  • History of ocular infection or ocular inflammation within the past three months in either eye.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution

Drug

Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension

Latanoprost 0.005% Ophthalmic Solution (XALATAN)

Drug

Commercially marketed ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension

Other names: XALATAN

Timolol 0.5% Ophthalmic Solution

Drug

Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension

Timolol Vehicle

Other

Placebo

Primary outcomes

  1. Mean Intraocular Pressure (IOP) Change at 3 Months from Baseline

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Feb 20, 2006
Registry last updated
Feb 14, 2012

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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