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)

Allergic Conjunctivitis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01275105
• Other study ID #: 10-100-0008
• Status: Completed
• Phase: Phase 2
• First received: January 10, 2011
• Last updated: March 2, 2012
• Start date: January 2011
• Est. completion date: March 2011

Study information

• Verified date: March 2012
• Source: Eye Therapies, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Vehicle
one drop in each eye at designated visits
• Brimonidine Tartrate 0.01%
one drop in each eye at designated visits
• Brimonidine Tartrate 0.025%
one drop in each eye at designated visits
• Oxymetazoline HCl 0.025%
one drop in each eye at designated visits

Locations

Country	Name	City	State
United States	Ora, Inc.	Andover	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Eye Therapies, LLC	ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conjunctival Redness		at specified timepoints for up to 30 minutes	No