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Completed

NCT Number: NCT01275105

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)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ora, Inc.

Andover, Massachusetts, 01810, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vehicle

Drug

one drop in each eye at designated visits

Brimonidine Tartrate 0.01%

Drug

one drop in each eye at designated visits

Brimonidine Tartrate 0.025%

Drug

one drop in each eye at designated visits

Oxymetazoline HCl 0.025%

Drug

one drop in each eye at designated visits

Primary outcomes

  1. Conjunctival Redness

    Time frame: at specified timepoints for up to 30 minutes

Sponsors and collaborators

Lead sponsor

Eye Therapies, LLC

Industry

Collaborators

  • ORA, Inc.

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 12, 2011
Registry last updated
Mar 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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