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Safety of Brimonidine Tartrate Ophthalmic Solution in a Population of Pediatric, Adult, and Geriatric Participants

NCT01959243 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 507

Last updated 2019-10-23

Study results available
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Summary

To compare the safety and tolerability of brimonidine tartrate ophthalmic solution 0.025% versus its vehicle in a population of pediatric, adult, and geriatric participants. At least 51% of participants will be 40 years of age or older.

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
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-22
Primary Completion
2014-04-23
Completion
2014-06-23

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 NCT01959243 on ClinicalTrials.gov