NCT01721707

Latanoprost/Brinzolamide BID Versus Latanoprost BID in Patients With OAG or OH

Safety and Efficacy to Reduce the IOP of the Fixed Association of Latanoprost 0.005% (50 μg/mL)/ Brinzolamide 1% (10mg/mL) Drops, Compared to Latanoprost 0.005% (50 μg/mL) Drops, in Patients With Open Angle Glaucoma or Ocular Hypertension

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Adapt Produtos Oftalmológicos Ltda. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a double-masked, randomized, parallel group study in patients with open angle glaucoma or ocular hypertension. The aim of this study is to verify the efficacy of the fixed combination of Latanoprost 50 mcg / mL / brinzolamide 10mg/ml eye drops compared to Latanoprost 50μg/mL eye drops in reducing IOP

Detailed description

The study is divided into two sequential phases. The Phase I trial is a Phase Screening / Eligibility, which includes a screening visit, followed by 2 Visits Eligibility (3 visits). The Phase II study is the treatment phase randomized, double-masked that includes visits during therapy at Week 2, Week 6 and Month 3

Conditions

• Open Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Latanoprost+Brinzolamide combination	1 drop in each eye, 1x/day, at 9PM
DRUG	Latanoprost	1 drop in each eye, 1x/day, at 9PM

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-03-01
• Completion: 2013-06-01
• First posted: 2012-11-06
• Last updated: 2014-12-11

Locations

1 site across 1 country: Brazil