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| Sponsor: | Merck |
|---|---|
| Information provided by: | Merck |
| ClinicalTrials.gov Identifier: | NCT00546286 |
Purpose
Evaluate the effectiveness of dorzolamide-timolol (Cosopt®) as first line therapy in reducing intraocular pressure in patients with untreated Open angle glaucoma (OAG) or Ocular hypertension (OH).
| Condition | Intervention | Phase |
|---|---|---|
|
Glaucoma Ocular Hypertension |
Drug: dorzolamide hydrochloride (+) timolol maleate Drug: Comparator: dorzolamide HCl/timolol maleate + prostaglandin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A 12 Week, Open-Label, Study to Evaluate the Effectiveness of Dorzolamide-Timolol as First Line Therapy to Reduce Intraocular Pressure in Patients With Untreated Open Angle Glaucoma (OAG) or Ocular Hypertension (OH) |
| Enrollment: | 170 |
| Study Start Date: | May 2006 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
dorzolamide HCl/timolol maleate
|
Drug: dorzolamide hydrochloride (+) timolol maleate
Combination treatment of dorzolamide HCl (2%)/ timolol maleate (0.5%) BID for six weeks in patients with open-angle glaucoma or ocular hypertension. For patients who achieve target IOP at 6 weeks, dorzolamide/timolol is continued for another 6 weeks. Other Name: Cosopt
|
|
Experimental: 2
dorzolamide hydrochloride/timolol maleate + prostaglandin
|
Drug: Comparator: dorzolamide HCl/timolol maleate + prostaglandin
Combination treatment of dorzolamide HCl (2%)/timolol maleate(0.5%) BID for six weeks in patients with open-angle glaucoma or ocular hypertension. For patients not achieving target IOP at 6 weeks, a prostaglandin is added for another 6 weeks. Other Name: Cosopt
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
| ClinicalTrials.gov Identifier: | NCT00546286 History of Changes |
| Other Study ID Numbers: | 2007_027, MK0507A-153 |
| Study First Received: | October 16, 2007 |
| Last Updated: | October 27, 2008 |
| Health Authority: | Canada: Health Canada |
|
Glaucoma Hypertension Ocular Hypertension Eye Diseases Vascular Diseases Cardiovascular Diseases Timolol Dorzolamide Maleic acid Adrenergic beta-Antagonists Adrenergic Antagonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Antihypertensive Agents Enzyme Inhibitors Carbonic Anhydrase Inhibitors |