A one month study which will determine the safety and efficacy of bimatoprost eye drops in patients with glaucoma or ocular hypertension

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• Drug: bimatoprost eye drops
  • 1 drop in each eye daily for 1 month
• Drug: placebo
  • 1 drop in each eye daily for 1 month

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• Conjunctival hyperemia
  • Time Frame: Month 1
    Safety Issue?: No

Secondary Measures

• IOP
  • Time Frame: Month 1
    Safety Issue?: No

Inclusion Criteria:

• Chronic glaucoma or ocular hypertension
• IOP controlled on Xalatan

Exclusion Criteria:

• Uncontrolled medical conditions
• Known hypersensitivity to study medications

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

Lead Sponsor: Allergan

Overall Clinical Trial Officials and Contacts

Overall Contact: Allergan Inc  clinicaltrials@allergan.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00538304

Study ID Number: 192024-035

ClinicalTrials.gov Identifier: NCT00538304

Health Authority: United States: Food and Drug Administration