Evaluation of Efficacy and Safety of an Anti-Allergy Drug With a Contact Lens in the Treatment of Allergic Conjunctivitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-05-31

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of an anti-allergy drug with a contact lens compared to placebo in preventing ocular itching associated with allergic conjunctivitis

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Detailed Description

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Conditions

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Allergic Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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Ketotifen with a Contact Lens (no generic name)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* History of ocular allergies and a positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees withing the past 24 months
* Successful soft contact lens wearer who has frequently worn contact lenses for at least one month or more

Exclusion Criteria

* Active ocular infection
* Clinically significant blepharitis
* Follicular conjunctivitis
* Pterygium
* Narrow angle glaucoma
* Dry eye dyndrome
* Ocular surgery within past 6 months
* Pregnancy or lactation

Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No