24-Hour Intraocular Pressure (IOP) Control With Travoprost/Timolol Fixed Combination
May 9, 2014 updated by: AGP Konstas, Aristotle University Of Thessaloniki
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
32
Phase
- Phase 3
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
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Thessaloniki, Greece, 546 36
- Glaucoma Unit, A University Dept of Ophthalmology, AHEPA Hospital
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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
29 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- POAG
- Exfoliation syndrome
Exclusion Criteria:
- Advanced glaucoma
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: Crossover Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: AGP Konstas, MD, PhD, Glaucoma Unit, A University Dept of Ophthalmology, AHEPA Hospital
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
March 1, 2006
Primary Completion (Actual)
January 1, 2007
Study Completion (Actual)
February 1, 2007
Study Registration Dates
First Submitted
May 26, 2006
First Submitted That Met QC Criteria
May 26, 2006
First Posted (Estimate)
May 29, 2006
Study Record Updates
Last Update Posted (Estimate)
May 12, 2014
Last Update Submitted That Met QC Criteria
May 9, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Ocular Hypertension
- Uveal Diseases
- Glaucoma
- Iris Diseases
- Glaucoma, Open-Angle
- Exfoliation Syndrome
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Pharmaceutical Solutions
- Ophthalmic Solutions
- Timolol
- Travoprost
- Lubricant Eye Drops
Other Study ID Numbers
- A1457
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.