To compare the 24-hour efficacy and safety, measured every three hours, of the dorzolamide/timolol fixed combination given twice daily versus latanoprost and placebo each given once daily...
Date First Received: January 6, 2006
Last Updated: January 8, 2007
Verified by: Pharmaceutical Research Network, January 2007
Clinical Trial Phase: Phase 4 | Start Date: April 2005
Overall Status: Completed
Brief Summary
Condition Keyword(s):
To compare the 24-hour efficacy and safety, measured every three hours, of the dorzolamide/timolol fixed combination given twice daily versus latanoprost and placebo each given once daily.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment
Intervention(s) in this Clinical Trial
- Drug: timolol maleate 0.5%
- Drug: dorzolamide/timolol maleate fixed combination
- Drug: latanoprost 0.005%
- Drug: placebo
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- adults with primary open-angle, pigmentary, or exfoliation glaucoma, or ocular hypertenstion
- intraocular pressure should be 22 to 30 mm Hg inclusive on timolol BID at the 08:00 H
- ETDRS visual acuity must be 1.0 or better in both eyes
Exclusion Criteria:
- any contraindications to study medications
- any anticipated change in systemic hypertensive therapy during the trial
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: Pharmaceutical Research Network
Overall Clinical Trial Officials and Contacts
William C. Stewart, MD Study Director Pharmaceutical Research Network, LLC
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00273429
Study ID Number: PRN 04-015
ClinicalTrials.gov Identifier: NCT00273429
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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