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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01275105
Other study ID # 10-100-0008
Secondary ID
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


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
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