Trial | NCT01275105  Report issue

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)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    brimonidine oxymetazoline ...

  • Study Participants

    68
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.
Study Started
Jan 31
2011
Primary Completion
Mar 31
2011
Study Completion
Mar 31
2011
Last Update
Mar 06
2012
Estimate

Drug Vehicle

one drop in each eye at designated visits

Drug Brimonidine Tartrate 0.01%

one drop in each eye at designated visits

Drug Brimonidine Tartrate 0.025%

one drop in each eye at designated visits

Drug Oxymetazoline HCl 0.025%

one drop in each eye at designated visits

Vehicle Other

Brimonidine Tartrate 0.01% Active Comparator

Oxymetazoline HCl 0.025% Active Comparator

Brimonidine Tartrate 0.025% Active Comparator

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.
No Results Posted