NCT02730871

Safety and Efficacy of SIMBRINZA® BID as an Adjunctive to DUOTRAV®

Safety and Efficacy With Twice Daily Brinzolamide 1%/Brimonidine 0.2% (SIMBRINZA®) as an Adjunctive Therapy to Travoprost 0.004%/Timolol 0.5% (DUOTRAV®)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the additive intraocular pressure (IOP) lowering effect of Brinzolamide 1%/Brimonidine 0.2% (SIMBRINZA®) dosed twice daily (BID) when added to Travoprost 0.004%/Timolol 0.5% (DUOTRAV®) in subjects with open-angle glaucoma or ocular hypertension.

Detailed description

This study is divided into 2 sequential phases for a total of 5 visits. Phase I of the study is the open-labeled Screening/Eligibility Phase, which includes a Screening Visit followed by 2 Eligibility Visits. Phase II of the study is the randomized, double-masked Treatment Phase, which includes 2 on-therapy visits: Visit 4 (at Week 2) and Visit 5 (Week 6, Exit Visit).

Conditions

• Open-angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
DRUG	Brinzolamide/brimonidine vehicle	Inactive ingredients used as placebo comparator
DRUG	Travoprost 0.004%/timolol 0.5% solution	1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for up to 10 days during the Screening/Eligibility Phase and 42 days during the Treatment Phase

Timeline

• Start date: 2016-06-24
• Primary completion: 2018-07-13
• Completion: 2018-07-13
• First posted: 2016-04-07
• Last updated: 2019-05-29
• Results posted: 2019-05-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study