Bimatoprost/Timolol Versus Travoprost/Timolol

March 1, 2012 updated by: Tamer A Macky, Kasr El Aini Hospital

Bimatoprost/Timolol Versus Travoprost/Timolol Fixed Combinations in an Egyptian Population: A Hospital-Based Prospective Randomized Study

The purpose of this study is to compare 2 fixed combination medications in intraocular pressure lowering.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PURPOSE: To compare the efficacy of bimatoprost/timolol (BTFC) or travoprost/timolol (TTFC) fixed combinations on intraocular pressure (IOP) reduction in an Egyptian population.

METHODS: Patients with primary open angle glaucoma (POAG) were randomized to receive either BTFC or TTFC. IOPs were measured at baseline, 2 weeks, and 1, 2, 4, and 6 months. The primary outcome measures were the mean change in IOP from baseline

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Kasr El Aini Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Glaucoma

Exclusion Criteria:

  • No other ocular diseases

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glaucoma fixed Combination Medications
Drug: Ganfort
Bimatoprost/Timolol fixed combination
Other Names:
  • Bimatoprost/Timolol vs Travoprost/Timolol fixed combination
Drug: Duotrav
Fixed combination of Travoprost and Timolol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of drop of intraocular pressures from baseline.
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Kasr El Aini Hospital

Investigators

  • Principal Investigator: Tamer A Macky, MD FRCS, Cairo University

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

January 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

February 6, 2012

First Submitted That Met QC Criteria

March 1, 2012

First Posted (Estimate)

March 2, 2012

Study Record Updates

Last Update Posted (Estimate)

March 2, 2012

Last Update Submitted That Met QC Criteria

March 1, 2012

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fixed Glaucoma Medications
  • GFDU-2011
  • GANDUO-2011 (Other Identifier: Cairo University)

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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