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)

NCT ID: NCT01275105

Last Updated: 2012-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-03-31

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.

Conditions

Allergic Conjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Vehicle

Group Type: OTHER

Vehicle

Intervention Type: DRUG

one drop in each eye at designated visits

Brimonidine Tartrate 0.01%

Group Type: ACTIVE_COMPARATOR

Brimonidine Tartrate 0.01%

Intervention Type: DRUG

one drop in each eye at designated visits

Oxymetazoline HCl 0.025%

Group Type: ACTIVE_COMPARATOR

Oxymetazoline HCl 0.025%

Intervention Type: DRUG

one drop in each eye at designated visits

Brimonidine Tartrate 0.025%

Group Type: ACTIVE_COMPARATOR

Brimonidine Tartrate 0.025%

Intervention Type: DRUG

one drop in each eye at designated visits

Interventions

Vehicle

one drop in each eye at designated visits

Intervention Type: DRUG

Brimonidine Tartrate 0.01%

one drop in each eye at designated visits

Intervention Type: DRUG

Brimonidine Tartrate 0.025%

one drop in each eye at designated visits

Intervention Type: DRUG

Oxymetazoline HCl 0.025%

one drop in each eye at designated visits

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ORA, Inc.

INDUSTRY

Sponsor Role: collaborator

Eye Therapies, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ora, Inc.

Andover, Massachusetts, United States

Countries

United States

Other Identifiers

10-100-0008

Identifier Type: -

Identifier Source: org_study_id