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Bimatoprost/Timolol Versus Travoprost/Timolol

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ganfort
Duotrav
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Glaucoma

Exclusion Criteria:

  • No other ocular diseases

Sites / Locations

  • Kasr El Aini Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Glaucoma fixed Combination Medications

Arm Description

Outcomes

Primary Outcome Measures

Percentage of drop of intraocular pressures from baseline.

Secondary Outcome Measures

Full Information

First Posted
February 6, 2012
Last Updated
March 1, 2012
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01542710
Brief Title
Bimatoprost/Timolol Versus Travoprost/Timolol
Official Title
Bimatoprost/Timolol Versus Travoprost/Timolol Fixed Combinations in an Egyptian Population: A Hospital-Based Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glaucoma fixed Combination Medications
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ganfort
Other Intervention Name(s)
Bimatoprost/Timolol vs Travoprost/Timolol fixed combination
Intervention Description
Bimatoprost/Timolol fixed combination
Intervention Type
Drug
Intervention Name(s)
Duotrav
Intervention Description
Fixed combination of Travoprost and Timolol
Primary Outcome Measure Information:
Title
Percentage of drop of intraocular pressures from baseline.
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Glaucoma Exclusion Criteria: No other ocular diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamer A Macky, MD FRCS
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr El Aini Hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

Bimatoprost/Timolol Versus Travoprost/Timolol

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