Lumigan Versus Cosopt

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

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