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: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

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

Primary Measures

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

Secondary Measures

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

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

Lead Sponsor: Allergan

Overall Clinical Trial Officials and Contacts

Medical Director Study Director Allergan  

Information obtained from ClinicalTrials.gov on July 02, 2009

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