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

Vistakon Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Allergic Conjunctivitis

Treatments: Drug: Ketotifen with a Contact Lens (no generic name)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00445874

06-003-23

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

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