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

Phase 3

Completed

• Conditions: Allergic Conjunctivitis

• Registration Number: NCT00445874
• Lead Sponsor: Vistakon Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-03-07
• Study First Submitted QC: 2007-03-08
• Study First Posted: 2007-03-09
• Study Completion: 2007-05
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-08
• Last Update Posted: 2009-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ocular itching

Secondary Outcome Measures

Name	Time	Method
Conjunctival, ciliary, and episcieral redness; chemosis and mucous discharge; tearing and lid swelling