A Study to Evaluate the Effectiveness of Cosopt® as First Line Therapy (MK-0507A-153)
|ClinicalTrials.gov Identifier: NCT00546286|
Recruitment Status : Completed
First Posted : October 18, 2007
Last Update Posted : April 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma Ocular Hypertension||Drug: dorzolamide hydrochloride (+) timolol maleate Drug: Comparator: dorzolamide HCl/timolol maleate + prostaglandin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||170 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||May 31, 2006|
|Primary Completion Date :||August 23, 2007|
|Study Completion Date :||August 23, 2007|
U.S. FDA Resources
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
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
- Reduction in IOP 4 mmHg (or >= 20%) over a period of 6 or 12 weeks. [ Time Frame: 6 to 12 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00546286
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|