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.

First Received on March 7, 2007. Last Updated on April 8, 2009 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind
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

Resource links provided by NLM:

MedlinePlus related topics: Allergy Drug Reactions Eye Wear Itching Pinkeye

Drug Information available for: Ketotifen Ketotifen fumarate

U.S. FDA Resources

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

Cincinnati, Ohio, United States

Fairfield, Ohio, United States

Mason, Ohio, United States

Sponsors and Collaborators

Vistakon Pharmaceuticals

Investigators

Study Director:

Brian Pall, OD, MS, FAAO

Vistakon Pharmaceutical

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00445874 History of Changes
Other Study ID Numbers:	06-003-23
Study First Received:	March 7, 2007
Last Updated:	April 8, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vistakon Pharmaceuticals:

allergic conjunctivitis, ophthalmology, multicenter, controlled

Additional relevant MeSH terms:

Conjunctivitis
Conjunctivitis, Allergic
Drug Hypersensitivity
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ketotifen
Anti-Allergic Agents

Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012