Safety and Efficacy Study of Bimatoprost in Ethnically Japanese Patients With Open-Angle Glaucoma or Ocular Hypertension

Verified by: Allergan, April 2008
First Received: April 1, 2008 | Last Updated: April 1, 2008 | Phase: Phase 2 | Start Date: November 2002
Overall Status: Completed | Estimated Enrollment: 111
  • …
  • Tell a FriendPrint

This study evaluates the safety and efficacy of once-daily bimatoprost 0.03% and 0.01% ophthalmic solutions compared with once-daily administered bimatoprost vehicle ophthalmic solution for 2 weeks in ethnically Japanese patients with open-angle glaucoma or ocular...

Brief Summary

This study evaluates the safety and efficacy of once-daily bimatoprost 0.03% and 0.01% ophthalmic solutions compared with once-daily administered bimatoprost vehicle ophthalmic solution for 2 weeks in ethnically Japanese patients with open-angle glaucoma or ocular hypertension

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: January 2004

Intervention(s) in this Clinical Trial

  • Drug: Bimatoprost 0.01% Ophthalmic Solution
    • Bimatoprost 0.01% ophthalmic solution 1 drop instilled in each eye once daily in the evening between 19:00 and 21:00
  • Drug: Bimatoprost 0.03% Ophthalmic Solution
    • Bimatoprost 0.03% ophthalmic solution 1 drop instilled in each eye once daily in the evening between 19:00 and 21:00
  • Drug: Bimatoprost Vehicle Ophthalmic Solution
    • Bimatoprost vehicle ophthalmic solution 1 drop instilled in each eye once daily in the evening between 19:00 and 21:00

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • Bimatoprost 0.01% Ophthalmic Solution
  • Experimental: 2
    • Bimatoprost 0.03% Ophthalmic Solution
  • Placebo Comparator: 3
    • Bimatoprost Vehicle Ophthalmic Solution

Outcome Measures for this Clinical Trial

Primary Measures

  • Intraocular pressure (IOP)
    • Time Frame: Day 14
      Safety Issue?: No

Secondary Measures

  • IOP
    • Time Frame: Days 2 and 7
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Ethnically Japanese patients with glaucoma or ocular hypertension in each eye who require IOP-lowering therapy in both eyes

Exclusion Criteria:

  • Uncontrolled systemic disease
  • Use of bimatoprost or an ocular prostaglandin (eg, latanoprost, travoprost) within 6 weeks prior to baseline (Day 0)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Allergan Industry

Overall Clinical Trial Officials and Contacts

Medical Director Study Director Allergan  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00651859

Study ID Number: 192024-024

ClinicalTrials.gov Identifier: NCT00651859

Health Authority: United States: Food and Drug Administration

Link to Clinical Trial Results

  • …
  • Tell a FriendPrint

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00651859