NCT02140060

6-Week Proof-of-Concept Study of Travoprost/Brinzolamide Ophthalmic Suspension in Subjects With Open-Angle Glaucoma or Ocular Hypertension

A 6-Week Proof-of-Concept Study Evaluating the Safety and IOP-Lowering Efficacy of Travoprost/Brinzolamide Fixed Combination Ophthalmic Suspension in Subjects With Open-Angle Glaucoma or Ocular Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 327 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate Travoprost/Brinzolamide fixed combination (Trav/Brinz) administered twice daily as compared to each of its marketed components (TRAVATAN Z® solution and AZOPT® suspension) and to the unfixed combination of TRAVATAN Z® plus AZOPT® in lowering intraocular pressure (IOP).

Detailed description

This study was divided into two phases conducted in sequence. Phase I was the Screening/Eligibility Phase, which included a Screening Visit, followed by two Eligibility Visits. Phase II was the randomized, double-masked, 6-week Treatment Phase which included on-therapy visits at Week 2 and Week 6. Travoprost was administered in 1 of 3 concentration levels (A-C), where A=lowest and C=highest.

Conditions

• Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Dose Level A / Brinzolamide 1% ophthalmic suspension	Fixed combination
DRUG	Dose Level B / Brinzolamide 1% ophthalmic suspension	Fixed combination
DRUG	Dose Level C / Brinzolamide 1% ophthalmic suspension	Fixed combination
DRUG	Brinzolamide 1% ophthalmic suspension AZOPT®
DRUG	Travoprost 0.004% ophthalmic solution TRAVATAN Z®
DRUG	Travoprost solution vehicle	Inactive ingredients used for masking purposes
DRUG	Brinzolamide suspension vehicle	Inactive ingredients used for masking purposes

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2014-05-16
• Last updated: 2015-12-29
• Results posted: 2015-12-29