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Sponsors and Collaborators: |
Aristotle University Of Thessaloniki Alcon Research |
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Information provided by: | Aristotle University Of Thessaloniki |
ClinicalTrials.gov Identifier: | NCT00444184 |
This 8-week, crossover study will compare the quality of 24-hour IOP control with TTFC versus travoprost when both medications are dosed in the evening. Such a crossover comparison may determine the real efficacy of the new fixed combination versus travoprost monotherapy. The results should enhance our understanding on the best dosing of TTFC and may influence its clinical use in Europe. Finally, the results would better delineate the future role of TTFC in glaucoma management after PG monotherapy, or instead of unfixed therapy with PG analogs and timolol. This study should assist the general ophthalmologist worldwide to plan optimal stepwise medical therapy.
Condition | Intervention | Phase |
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Glaucoma |
Drug: Travoprost/timolol fixed combination, travoprost |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Active Control, Crossover Assignment, Efficacy Study |
Official Title: | A Crossover, Double-Masked Comparison Investigating the 24-Hour Intraocular Pressure Control With the Travoprost/Timolol Fixed Combination Versus Travoprost, When Both Are Given in the Evening, in Subjects With Primary Open-Angle Glaucoma |
Enrollment: | 32 |
Study Start Date: | March 2007 |
Study Completion Date: | January 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 29 Years to 81 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Greece | |
Glaucoma Unit, 1st University Department of Ophthalmology | |
Thessaloniki, Greece, 546 36 |
Principal Investigator: | Anastasios GP Konstas, MD, PhD | Associate Professor and Head of the Glaucoma Unit, 1st University Department of Ophthalmology |
Study ID Numbers: | A3243 |
Study First Received: | March 5, 2007 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00444184 |
Health Authority: | Greece: National Organization of Medicines |
travoprost/timolol fixed combination |
Glaucoma Eye Diseases Glaucoma, Open-Angle Timolol |
Travoprost Hypertension Ocular Hypertension |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Therapeutic Uses Physiological Effects of Drugs Adrenergic beta-Antagonists |
Adrenergic Antagonists Cardiovascular Agents Anti-Arrhythmia Agents Antihypertensive Agents Pharmacologic Actions |