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

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eye Therapies, LLC
• Collaborator: ORA, Inc.
• Treatments: Brimonidine Tartrate; Ophthalmic Solutions; Oxymetazoline; Phenylephrine

Criteria

Inclusion Criteria:

• Be at least 18 years of age;

• If female, cannot be not pregnant or nursing

• Have a positive skin test reaction to cat hair, cat dander, grasses, ragweed, dog dander, cockroach, dust mite, and/or trees within the past 24 months;

• Have a calculated best corrected visual acuity of 0.6 logMAR or better in each eye as measured using an ETDRS chart;

Exclusion Criteria:

• Have known contraindications or sensitivities to the use of any of the study medications(s) or their components;

• Have any ocular condition that, in the opinion of the investigator, could affect the subject's safety;

• Have a presence of active ocular infection;

• Use specified disallowed medications during the study or appropriate pre-study washout period;

• Have any significant illness;

• Have planned surgery (ocular or systemic) during the trial period or within 30 days after;

• Have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study;

• Be a female who is currently pregnant or nursing.