A Safety and Efficacy Study of Fixed-Combination Bimatoprost and Brimonidine in Chronic Glaucoma or Ocular Hypertension
Information source: Allergan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma; Ocular Hypertension
Intervention: Fixed-Combination Bimatoprost/Brimonidine (Drug); Bimatoprost Ophthalmic Solution 0.01% (Drug); Vehicle Ophthalmic Solution (Drug); Brimonidine Tartrate Ophthalmic Solution 0.2% (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Allergan Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan
Summary
This is a safety and efficacy study of fixed-combination bimatoprost and brimonidine
compared with LUMIGANŽ and ALPHAGANŽ in patients with chronic glaucoma or ocular
hypertension.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP)
Secondary outcome: Change From Baseline in Average Eye Mean Diurnal IOPAverage Eye Mean Diurnal IOP
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of ocular hypertension or glaucoma
- Requires intraocular pressure (IOP)-lowering therapy
Exclusion Criteria:
- Cataract surgery in one eye
- Ocular laser or intraocular surgery within 6 months
- Refractive surgery in either eye
- Anticipated use of contact lenses during the study
- Expected use of artificial tears during the study
Locations and Contacts
Newport Beach, California, United States
Additional Information
Starting date: June 2013
Last updated: January 16, 2015
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