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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00331240
Recruitment Status : Completed
First Posted : May 29, 2006
Last Update Posted : May 12, 2014
Sponsor:
Information provided by (Responsible Party):
AGP Konstas, Aristotle University Of Thessaloniki

Study Description
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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.

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Exfoliation Syndrome Drug: travoprost/timolol fixed combination Drug: placebo (artificial tears) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 24-Hour Intraocular Pressure (IOP) Control With Travoprost/Timolol Fixed Combination
Study Start Date : March 2006
Actual Primary Completion Date : January 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   29 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • POAG
  • Exfoliation syndrome

Exclusion Criteria:

  • Advanced glaucoma
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00331240


Locations
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Greece
Glaucoma Unit, A University Dept of Ophthalmology, AHEPA Hospital
Thessaloniki, Greece, 546 36
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
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Principal Investigator: AGP Konstas, MD, PhD Glaucoma Unit, A University Dept of Ophthalmology, AHEPA Hospital
More Information
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Responsible Party: AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT00331240    
Other Study ID Numbers: A1457
First Posted: May 29, 2006    Key Record Dates
Last Update Posted: May 12, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Exfoliation Syndrome
Glaucoma
Ocular Hypertension
Eye Diseases
Iris Diseases
Uveal Diseases
Timolol
Travoprost
Lubricant Eye Drops
 Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Ophthalmic Solutions
Pharmaceutical Solutions