This study is comparing 2 medications for glaucoma and how effective they are at controlling glaucoma over the course of an entire day...
Date First Received: April 12, 2005
Last Updated: May 19, 2009
Verified by: Merck, May 2009
Clinical Trial Phase: Phase 3 | Start Date: July 2005
Overall Status: Completed
Estimated Enrollment: 330
Brief Summary
Official Title: “Randomized, Multicenter, Dbl-Masked, Parallel Study Evaluating the 24 Hr. Diurnal Ocular Hypotensive Effect of 2% Dorzolamide Hydrochloride/0.5% Timolol Maleate Combo. Ophthalmic Sol. in Patients w/ Open Angle Glaucoma or Ocular Hypertension”
Condition Keyword(s):
This study is comparing 2 medications for glaucoma and how effective they are at controlling glaucoma over the course of an entire day.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: MK0507A, dorzolamide hydrochloride (+) timolol maleate
- Drug: Comparator: timolol maleate
- Drug: Duration of Treatment: Part 1) 6 wk timolol maleate run in
- Drug: Part 2) 6 wk washout pd Part 3) two 8 wk active tx pds
Outcome Measures for this Clinical Trial
Primary Measures
- 24 hour diurnal IOP reduction after 8 weeks of treatment
- Time Frame: After 8 weeks of treatment
Safety Issue?: No
- Time Frame: After 8 weeks of treatment
Secondary Measures
- IOP reduction a) from baseline at 6 weeks; b) comparison with timolol; c) comparison day versus night
- Time Frame: At 6 weeks
Safety Issue?: No
- Time Frame: At 6 weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patients with glaucoma or ocular hypertension
Exclusion Criteria:
- Other eye conditions
- Poor vision
- Recent eye surgery
- Use of contact lenses
- Nursing or pregnant women
- Use of some other selected medications
- Drug or alcohol abuse
- Asthma
- Slow heart beat
- Allergy or previous reaction to study drugs
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Merck
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Related Publications
References
Feldman RM, Stewart RH, Stewart WC, Jia G, Smugar SS, Galet VA. 24-hour control of intraocular pressure with 2% dorzolamide/0.5% timolol fixed-combination ophthalmic solution in open-angle glaucoma. Curr Med Res Opin. 2008 Jul 14; [Epub ahead of print]
Olander KW, Galet VA, Jia G, Smugar SS, Stewart WC. Relationship Between Visual Field Severity and Response to Fixed Combination Dorzolamide/Timolol or Timolol Alone. J Ocul Pharmacol Ther. 2009 May 14; [Epub ahead of print]
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00108017
Study ID Number: 2005_021
ClinicalTrials.gov Identifier: NCT00108017
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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