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Sponsors and Collaborators: |
Aristotle University Of Thessaloniki Merck |
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Information provided by: | Aristotle University Of Thessaloniki |
ClinicalTrials.gov Identifier: | NCT00397241 |
The primary objective of this crossover trial is to compare the 3-month mean 24-hour intraocular pressure (IOP) control and safety of dorzolamide/timolol fixed combination (DTFC) given twice daily, versus latanoprost/timolol fixed combination (LTFC) given in the evening and placebo given in the morning, versus adjunctive therapy with DTFC given twice daily and latanoprost 0.005% given once in the evening in open-angle glaucoma patients who are insufficiently controlled with latanoprost monotherapy.
Condition | Intervention | Phase |
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Open-Angle Glaucoma |
Drug: Drug: dorzolamide/timolol Drug: Drug: latanoprost/timolol Drug: dorzolamide/timolol and latanoprost Drug: placebo (artificial tears) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | 24-Hour IOP With DTFC and LTFC Monotherapies and the Adjunctive Therapy of DTFC and Latanoprost in Open-Angle Glaucoma Insufficiently Controlled With Latanoprost Monotherapy. |
Enrollment: | 33 |
Study Start Date: | September 2006 |
Study Completion Date: | October 2007 |
Ages Eligible for Study: | 29 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Greece | |
Glaucoma Unit, A University Dept of Ophthalmology | |
Thessaloniki, Greece, 546 43 |
Principal Investigator: | Anastasios GP Konstas, MD, PhD | Glaucoma Unit, A University Department of Ophthalmology, AHEPA Hospital, Thessaloniki, Greece |
Study ID Numbers: | A733 |
Study First Received: | November 6, 2006 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00397241 History of Changes |
Health Authority: | Greece: National Organization of Medicines |
Neurotransmitter Agents Adrenergic Agents Eye Diseases Cardiovascular Agents Antihypertensive Agents Latanoprost Carbonic Anhydrase Inhibitors Glaucoma |
Glaucoma, Open-Angle Adrenergic beta-Antagonists Adrenergic Antagonists Timolol Anti-Arrhythmia Agents Ocular Hypertension Hypertension Dorzolamide |
Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Eye Diseases Physiological Effects of Drugs Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Latanoprost Pharmacologic Actions |
Carbonic Anhydrase Inhibitors Glaucoma Therapeutic Uses Glaucoma, Open-Angle Adrenergic beta-Antagonists Adrenergic Antagonists Anti-Arrhythmia Agents Timolol Ocular Hypertension Dorzolamide |