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)
Phase 2
Completed
- Conditions
- Allergic Conjunctivitis
- Interventions
- Registration Number
- NCT01275105
- Lead Sponsor
- Eye Therapies, LLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Brimonidine Tartrate 0.01% Brimonidine Tartrate 0.01% - Vehicle Vehicle - Oxymetazoline HCl 0.025% Oxymetazoline HCl 0.025% - Brimonidine Tartrate 0.025% Brimonidine Tartrate 0.025% -
- Primary Outcome Measures
Name Time Method Conjunctival Redness at specified timepoints for up to 30 minutes
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ora, Inc.
🇺🇸Andover, Massachusetts, United States