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

NCT02730871 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2019-05-29

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Assoc Global Trial Director, TM Ophtha · 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
2016-06-24
Primary Completion
2018-07-13
Completion
2018-07-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT02730871 on ClinicalTrials.gov