Comparison of Istalol™ 0.5% QD (Timolol Maleate/Sorbitol Complex, ISTA Pharmaceutical) to Brimonidine Tartrate 0.1% BID as Adjunctive Therapy to Latanoprost 0.005% in Adults With Ocular Hypertension (OHT) or Open-Angle Glaucoma (OAG)
NCT00698945 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2008-12-04
Summary
To assess the additional benefit of common adjunctive classes on the diurnal IOP curve in patients assessed as needing additional treatment to reach target intraocular pressure (IOP). To demonstrate superiority of IOP control with Istalol 0.5% QD compared to Brimonidine Tartrate 0.2% BID as adjunctive therapy in adults with uncontrolled IOP's (determined by P.I. based on target pressures) currently treated with Latanoprost 0.05% in the study eye(s).
Conditions
- Ocular Hypertension
- Open-Angle Glaucoma
Interventions
- DRUG
-
Istalol and Optive
Istalol: one drop a day for 28 days Optive: one drop a day for 28 days
- DRUG
-
Alphagan
Alphagan: two drops a day for 28 days
Sponsors & Collaborators
-
Bp Consulting, Inc
lead NETWORK
Principal Investigators
-
Jason Bacharach, M.D · North Bay Eye Associates,Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-06-30
- Primary Completion
- 2008-11-30
- Completion
- 2008-11-30
Countries
- United States
Study Locations
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