Official Title: “A Multi-Center, Randomized, Double-Masked, Placebo-Controlled Evaluation of the Efficacy and Safety of an Anti-Allergy Drug With a Contact Lens as Compared to Placebo in the Prevention of Allergic Conjunctivitis in a Population of Allergic Contact Lens Wearers”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Ketotifen with a Contact Lens (generic name not yet established)

Primary Measures

• Ocular itching

Secondary Measures

• Conjunctival, ciliary, and episcleral redness; chemosis and mucous discharge; tearing and lid swelling

Inclusion Criteria:

• history of ocular allergies and a positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within 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 syndrome; ocular surgery within past 6 months; pregnancy or lactation

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 8 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Vistakon Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Brian Pall, OD, MS, FAAO Study Director Vistakon Pharmaceuticals  

Information obtained from ClinicalTrials.gov on January 08, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00432757

Study ID Number: 06-003-15

ClinicalTrials.gov Identifier: NCT00432757

Health Authority: United States: Food and Drug Administration