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)
Information source: Eye Therapies, LLC
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergic Conjunctivitis
Intervention: Vehicle (Drug); Brimonidine Tartrate 0.01% (Drug); Brimonidine Tartrate 0.025% (Drug); Oxymetazoline HCl 0.025% (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Eye Therapies, LLC
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.
Clinical Details
Official title: 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)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: Conjunctival Redness
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Ora, Inc., Andover, Massachusetts 01810, United States
Additional Information
Starting date: January 2011
Last updated: March 2, 2012
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