To compare the intraocular pressure effect and safety of the dorzolamide/timolol fixed combination given twice daily versus bimatoprost given once every evening in patients with open-angle glaucoma in patients insufficiently controlled on latanoprost...
Date First Received: January 6, 2006
Last Updated: March 30, 2007
Verified by: Pharmaceutical Research Network, March 2007
Clinical Trial Phase: Phase 4 | Start Date: January 2006
Overall Status: Completed
Estimated Enrollment: 34
Brief Summary
Condition Keyword(s):
To compare the intraocular pressure effect and safety of the dorzolamide/timolol fixed combination given twice daily versus bimatoprost given once every evening in patients with open-angle glaucoma in patients insufficiently controlled on latanoprost monotherapy
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment
Intervention(s) in this Clinical Trial
- Drug: bimatoprost 0.03%
- Drug: dorzolamide 2%/timolol maleate 0.5% fixed combination
- Drug: placebo
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- adults with a diagnosis of bilateral open-angle glaucoma including: primary, pigment dispersion or exfoliation in both eyes
- on no therapy the intraocular pressure should be 22-29 mm Hg inclusive at the 8:00 AM measurement
- visual acuity should be 20/200 or better in each eye
Exclusion Criteria:
- historical failure to respond to topical beta-blockers in a clinically meaningful manner
- any contraindication to study medications
- any anticipated change, or modification in the 6 weeks prior to Visit 1, 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 07, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00273455
Study ID Number: PRN 05-017
ClinicalTrials.gov Identifier: NCT00273455
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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