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

February 13, 2012 updated by: Alcon Research
The purpose of the study is to evaluate the safety and effectiveness of an investigational therapy for treating patients with open-angle glaucoma or ocular hypertension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years or older.
  • Diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension.
  • Mean IOP in each eye less than 18 mmHg at the screening visit.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Pregnant.
  • History of chronic or recurrent severe inflammatory eye disease.
  • Ocular trauma within the past six months in either eye.
  • Other protocol-defined exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Travoprost 0.004%/Timolol 0.5%
Travoprost 0.004%/Timolol 0.5% in both eyes each morning at 8 a.m. and Timolol vehicle in both eyes each evening at 8 p.m. for 3 months
Other: Timolol Vehicle
Placebo
Drug: Travoprost 0.004% / Timolol 0.5% Ophthalmic Solution
Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
Active Comparator: Xalatan + Timolol 0.5%
Timolol 0.5% in both eyes each morning at 8 a.m. and Xalatan in both eyes each evening at 8 p.m. for 3 months
Drug: Latanoprost 0.005% Ophthalmic Solution (XALATAN)
Commercially marketed ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension
Other Names:
  • XALATAN
Drug: Timolol Maleate Ophthalmic Solution 0.5%
Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean intraocular pressure (IOP) change at 3 months from baseline
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

February 17, 2006

First Submitted That Met QC Criteria

February 17, 2006

First Posted (Estimate)

February 20, 2006

Study Record Updates

Last Update Posted (Estimate)

February 14, 2012

Last Update Submitted That Met QC Criteria

February 13, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-04-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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