Brimonidine 0.1% Versus Brinzolamide 1% as Adjunctive Therapy to Latanoprost 0.005%

Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering will be randomized to receive either brimonidine 0.1% or brinzolamide 1% three-times daily as adjunctive therapy to latanoprost 0...

Date First Received: February 22, 2007

Last Updated: December 26, 2007

Verified by: Allergan, December 2007

Clinical Trial Phase: Phase 4 | Start Date: July 2006

Overall Status: Completed

Estimated Enrollment: 40

Brief Summary

Condition Keyword(s):

Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering will be randomized to receive either brimonidine 0.1% or brinzolamide 1% three-times daily as adjunctive therapy to latanoprost 0.005%

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2007

Intervention(s) in this Clinical Trial

  • Drug: latanoprost 0.005% eye drops and brimonidine 0.1% eye drops
    • latanoprost 0.005%, 1 drop nightly for 3 months and brimonidine 0.1% three-times daily for 3 months
  • Drug: latanoprost 0.005% eye drops and brinzolamide 1.0% eye drops
    • latanoprost 0.005% 1 drop nightly for 3 months AND brinzolamide 1.0% 1% three-times daily for 3 months

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
  • Active Comparator: 2

Outcome Measures for this Clinical Trial

Primary Measures

  • IOP
    • Time Frame: Month 3
      Safety Issue?: No

Secondary Measures

  • Tolerability
    • Time Frame: Month 3
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Glaucoma or ocular hypertension in both eyes
  • Currently being treated with latanoprost 0.005% QD
  • IOP greater than or equal to 18mm Hg on latanoprost 0.005%
  • Best-corrected VA of 20/200 or better in each eye
  • Visual field within 6 months of study entry

Exclusion Criteria:

  • Secondary glaucoma
  • Active intraocular inflammation or macular edema
  • Intraocular surgery or laser surgery within the past 3 months

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: Allergan

Overall Clinical Trial Officials and Contacts

Medical Affairs Study Director Allergan  

Additional Information

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00440141

Study ID Number: MA-AP01

ClinicalTrials.gov Identifier: NCT00440141

Health Authority: United States: Institutional Review Board

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