To assess the safety and efficacy of a cohort of patients switched to the dorzolamide/timolol maleate fixed combination because they are insufficiently controlled on latanoprost monotherapy...
Date First Received: January 6, 2006
Last Updated: April 30, 2007
Verified by: Pharmaceutical Research Network, April 2007
Clinical Trial Phase: Phase 4 | Start Date: November 2005
Overall Status: Completed
Estimated Enrollment: 60
Brief Summary
Condition Keyword(s):
Intervention(s):
To assess the safety and efficacy of a cohort of patients switched to the dorzolamide/timolol maleate fixed combination because they are insufficiently controlled on latanoprost monotherapy.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment
Intervention(s) in this Clinical Trial
- Drug: timolol maleate
- Drug: dorzolamide/timolol maleate fixed combination
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- adults with clinical diagnosis of POAG, pigment-dispersion or exfoliation glaucoma or ocular hypertension
- the IOP on latanoprost must be 31 mm Hg or less in both eyes, and 21 to 31 mm Hg inclusive in at least one eye at 08:00 AM
- visual acuity should be 20/200 or better in each eye
Exclusion Criteria:
- contraindications to study drugs
- anticipated change in systemic hypotensive therapy during the trial
- use of any corticosteroids by any route in the three months immediately prior to Visit 2
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/NCT00273442
Study ID Number: PRN 05-007
ClinicalTrials.gov Identifier: NCT00273442
Health Authority: United States: Institutional Review Board
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