NCT00698945

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)

Randomized, Investigator Masked 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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Bp Consulting, Inc · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2008-06-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2008-06-17
• Last updated: 2008-12-04

Locations

1 site across 1 country: United States