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

NCT02140060 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 327

Last updated 2015-12-29

Study results available
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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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Sr. Clinical Manager, GCRA, Pharma · Alcon Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-11-30
Completion
2014-11-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02140060 on ClinicalTrials.gov