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NCT01542710 Clinical Trial

Bimatoprost/Timolol Versus Travoprost/Timolol

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01542710
Other study ID # Fixed Glaucoma Medications
Secondary ID GFDU-2011GANDUO-
Status Completed
Phase N/A
First received February 6, 2012
Last updated March 1, 2012
Start date January 2011
Est. completion date December 2011

Study information
Verified date January 2011
Source Kasr El Aini Hospital
Contact n/a
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Glaucoma

Exclusion Criteria:

- No other ocular diseases

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ganfort
Bimatoprost/Timolol fixed combination
• Duotrav
Fixed combination of Travoprost and Timolol

Locations
Country Name City State
Egypt Kasr El Aini Hospital Cairo

Sponsors (1)
Lead Sponsor Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of drop of intraocular pressures from baseline. 1 year Yes
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