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

This study has been completed.

Sponsored by:	Vistakon Pharmaceuticals
Information provided by:	Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00445874

Purpose

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

Condition	Intervention	Phase
Allergic Conjunctivitis	Drug: Ketotifen with a Contact Lens (no generic name)	Phase III

MedlinePlus related topics: Allergy Eye Wear

Drug Information available for: Ketotifen Ketotifen fumarate

U.S. FDA Resources

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

Further study details as provided by Vistakon Pharmaceuticals:

Primary Outcome Measures:

Ocular itching

Secondary Outcome Measures:

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

Estimated Enrollment:	120
Study Start Date:	February 2007
Study Completion Date:	May 2007

Eligibility

Ages Eligible for Study:	8 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445874

Locations

United States, Arizona

Phoenix, Arizona, United States

Phoenix, Arizona, United States, 85032
United States, California

Irvine, California, United States
United States, Massachusetts

North Andover, Massachusetts, United States
United States, Ohio

Mason, Ohio, United States

Fairfield, Ohio, United States

Cincinnati, Ohio, United States

Sponsors and Collaborators

Vistakon Pharmaceuticals

Investigators

Study Director:

Brian Pall, OD, MS, FAAO

Vistakon Pharmaceutical

More Information

Study ID Numbers:	06-003-23
Study First Received:	March 7, 2007
Last Updated:	September 21, 2007
ClinicalTrials.gov Identifier:	NCT00445874
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vistakon Pharmaceuticals:

allergic conjunctivitis, ophthalmology, multicenter, controlled

Study placed in the following topic categories:

Hypersensitivity
Ketotifen
Conjunctivitis, Allergic
Eye Diseases

Hypersensitivity, Immediate
Conjunctivitis
Conjunctival Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009