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 | Completed Phase 2

• 1 other identifier: 10-100-0008
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Conjunctival Redness

  at specified timepoints for up to 30 minutes

Study Arms (4)

Vehicle

OTHER

Drug: Vehicle

Brimonidine Tartrate 0.01%

ACTIVE COMPARATOR

Drug: Brimonidine Tartrate 0.01%

Oxymetazoline HCl 0.025%

ACTIVE COMPARATOR

Drug: Oxymetazoline HCl 0.025%

Brimonidine Tartrate 0.025%

ACTIVE COMPARATOR

Drug: Brimonidine Tartrate 0.025%

Interventions

Vehicle DRUG

one drop in each eye at designated visits

Vehicle

Brimonidine Tartrate 0.01% DRUG

one drop in each eye at designated visits

Brimonidine Tartrate 0.01%

Brimonidine Tartrate 0.025% DRUG

one drop in each eye at designated visits

Brimonidine Tartrate 0.025%

Oxymetazoline HCl 0.025% DRUG

one drop in each eye at designated visits

Oxymetazoline HCl 0.025%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eye Therapies, LLC: lead
• ORA, Inc.: collaborator

Study Sites (1)

Ora, Inc.

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2011
• First Posted: January 12, 2011
• Study Start: January 1, 2011
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 6, 2012

Record last verified: 2012-03

Locations

US (1)