Safety and Efficacy Study of Different Formulations of Bimatoprost Once-Daily in Patients With Glaucoma or Ocular Hypertension

This study evaluates the safety and efficacy of different formulations of bimatoprost ophthalmic solution compared with Bimatoprost 0.03% once-daily in patients with glaucoma or ocular hypertension. One of the test formulations was given to one eye and bimatoprost 0.03% given to the fellow eye of each patient

Intervention(s) in this Clinical Trial

• Drug: Bimatoprost 0.01% ophthalmic solution
  • One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop
• Drug: Bimatoprost 0.015% formulation 1 ophthalmic solution
  • One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop
• Drug: Bimatoprost 0.015% formulation 2 ophthalmic solution
  • One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop
• Drug: Bimatoprost 0.02% ophthalmic solution
  • One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop
• Drug: Bimatoprost 0.03% ophthalmic solution
  • Bimatoprost 0.03% ophthalmic solution, one drop in one eye, once daily in the morning for 4 consecutive days, the other eye received one drop of any of the 4 study drugs

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Bimatoprost 0.01% ophthalmic solution
• Experimental: 2
  • Bimatoprost 0.015% formulation 1 ophthalmic solution
• Experimental: 3
  • Bimatoprost 0.015% formulation 2 ophthalmic solution
• Experimental: 4
  • Bimatoprost 0.02% ophthalmic solution
• Active Comparator: 5
  • Bimatoprost 0.03% ophthalmic solution

Primary Measures

• Intraocular pressure (IOP)
  • Time Frame: Day 5
    Safety Issue?: No

Secondary Measures

• Patient Comfort
  • Time Frame: Days 1-4
    Safety Issue?: No
• Patient Satisfaction
  • Time Frame: Day 5
    Safety Issue?: No
• Treatment Preference
  • Time Frame: Day 5
    Safety Issue?: No

Inclusion Criteria:

• Ocular hypertension or glaucoma in both eyes
• Require IOP-lowering therapy in each eye

Exclusion Criteria:

• Uncontrolled systemic disease
• Known allergy or hypersensitivity to bimatoprost

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 Investigator: Allergan Industry

Overall Clinical Trial Officials and Contacts

Medical Director Study Director Allergan  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00652496

Study ID Number: 192024-030

ClinicalTrials.gov Identifier: NCT00652496

Health Authority: United States: Food and Drug Administration