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Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Participants With Ocular Redness

NCT01959230 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-10-23

Study results available
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Summary

To compare the efficacy and safety of brimonidine tartrate ophthalmic solution 0.025% with its vehicle for the treatment of ocular redness in a population of adult and geriatric participants with ocular redness.

Conditions

  • Hyperemia

Interventions

DRUG

Brimonidine Tartrate

Ophthalmic solution to be applied as directed.

DRUG

Vehicle

Ophthalmic solution to be applied as directed.

DRUG

Sodium Fluorescein

For use as needed during the study for evaluating corneal damage.

DRUG

Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP

For use as needed during the study for intraocular pressure and dilated ophthalmoscopy.

Sponsors & Collaborators

  • ORA, Inc.

    collaborator INDUSTRY

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Heleen DeCory · Bausch & Lomb Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-07
Primary Completion
2013-12-20
Completion
2013-12-20

Countries

  • United States

Study Locations

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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 NCT01959230 on ClinicalTrials.gov