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A Single-Center, Randomized, Double-Masked, Placebo and Active Controlled, Dose-Ranging Evaluation of the Duration of Action of Brimonidine Tartrate Ophthalmic Solution in the Control of Ocular Redness Induced by Conjunctival Allergen Challenge (CAC)

NCT01275105 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2012-03-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, efficacy, and dose response of brimonidine tartrate ophthalmic solution as compared to placebo in the prevention of allergen-induced conjunctival redness using a conjunctival allergen challenge (CAC) model.

It is hypothesized that low-dose brimonidine tartrate ophthalmic solution will be more effective than vehicle in the prevention of conjunctival redness induced by conjunctival allergen challenge when instilled prior to the allergen challenge.

Conditions

  • Allergic Conjunctivitis

Interventions

DRUG

Vehicle

one drop in each eye at designated visits

DRUG

Brimonidine Tartrate 0.01%

one drop in each eye at designated visits

DRUG

Brimonidine Tartrate 0.025%

one drop in each eye at designated visits

DRUG

Oxymetazoline HCl 0.025%

one drop in each eye at designated visits

Sponsors & Collaborators

  • ORA, Inc.

    collaborator INDUSTRY

  • Eye Therapies, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-03-31
Completion
2011-03-31

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 NCT01275105 on ClinicalTrials.gov