Assessing Cosopt Switch Patients

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

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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