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24-Hour Intraocular Pressure (IOP) Control With Travoprost/Timolol Fixed Combination

Primary Purpose

Primary Open Angle Glaucoma, Exfoliation Syndrome

Status
Completed
Phase
Phase 3
Locations
Greece
Study Type
Interventional
Intervention
travoprost/timolol fixed combination
placebo (artificial tears)
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma

Eligibility Criteria

29 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: POAG Exfoliation syndrome Exclusion Criteria: Advanced glaucoma

Sites / Locations

  • Glaucoma Unit, A University Dept of Ophthalmology, AHEPA Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 26, 2006
Last Updated
May 9, 2014
Sponsor
Aristotle University Of Thessaloniki
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1. Study Identification

Unique Protocol Identification Number
NCT00331240
Brief Title
24-Hour Intraocular Pressure (IOP) Control With Travoprost/Timolol Fixed Combination
Official Title
24-Hour Intraocular Pressure (IOP) Control With Travoprost/Timolol Fixed Combination
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the short-term (8 week) mean 24-hour intraocular pressure control and safety of TravTim fixed combination given once in the evening with placebo once in the morning versus TravTim given once in the morning with placebo once in the evening in patients with open-angle glaucoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma, Exfoliation Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
32 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
travoprost/timolol fixed combination
Intervention Type
Drug
Intervention Name(s)
placebo (artificial tears)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
29 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: POAG Exfoliation syndrome Exclusion Criteria: Advanced glaucoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AGP Konstas, MD, PhD
Organizational Affiliation
Glaucoma Unit, A University Dept of Ophthalmology, AHEPA Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glaucoma Unit, A University Dept of Ophthalmology, AHEPA Hospital
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece

12. IPD Sharing Statement

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24-Hour Intraocular Pressure (IOP) Control With Travoprost/Timolol Fixed Combination

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