Safety and Efficacy Study of Different Formulations of Bimatoprost Once-Daily in Patients With Glaucoma or Ocular Hypertension
Phase 2
Completed
- Conditions
- GlaucomaOcular Hypertension
- Interventions
- Registration Number
- NCT00652496
- Lead Sponsor
- Allergan
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 249
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 Bimatoprost 0.015% formulation 2 ophthalmic solution Bimatoprost 0.015% formulation 2 ophthalmic solution 5 Bimatoprost 0.03% ophthalmic solution Bimatoprost 0.03% ophthalmic solution 4 Bimatoprost 0.02% ophthalmic solution Bimatoprost 0.02% ophthalmic solution 1 Bimatoprost 0.01% ophthalmic solution Bimatoprost 0.01% ophthalmic solution 2 Bimatoprost 0.015% formulation 1 ophthalmic solution Bimatoprost 0.015% formulation 1 ophthalmic solution
- Primary Outcome Measures
Name Time Method Intraocular pressure (IOP) Day 5
- Secondary Outcome Measures
Name Time Method Patient Comfort Days 1-4 Patient Satisfaction Day 5 Treatment Preference Day 5