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

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ClinicalTrials.gov Identifier: NCT00432757
Recruitment Status : Completed
First Posted : February 8, 2007
Last Update Posted : April 9, 2009
Information provided by:
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

Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: Ketotifen with a Contact Lens (generic name not yet established) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : January 2007
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Ketotifen
U.S. FDA Resources

Primary Outcome Measures :
  1. Ocular itching

Secondary Outcome Measures :
  1. Conjunctival, ciliary, and episcleral redness; chemosis and mucous discharge; tearing and lid swelling

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00432757

United States, California
Los Angeles, California, United States
United States, North Carolina
Charlotte, North Carolina, United States
United States, Tennessee
Memphis, Tennessee, United States
Sponsors and Collaborators
Vistakon Pharmaceuticals
Study Director: Brian Pall, OD, MS, FAAO Vistakon Pharmaceuticals

ClinicalTrials.gov Identifier: NCT00432757     History of Changes
Other Study ID Numbers: 06-003-15
First Posted: February 8, 2007    Key Record Dates
Last Update Posted: April 9, 2009
Last Verified: April 2009

Keywords provided by Vistakon Pharmaceuticals:
allergic conjunctivitis, ophthalmology, multicenter, controlled

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Drug Hypersensitivity
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Anti-Allergic Agents
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs