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

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ClinicalTrials.gov Identifier: NCT00445874
Recruitment Status : Completed
First Posted : March 9, 2007
Last Update Posted : April 9, 2009
Sponsor:
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 (no generic name) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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 : February 2007
Actual Study Completion Date : May 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 episcieral 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
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

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): NCT00445874


Locations
United States, Arizona
Phoenix, Arizona, United States, 85032
Phoenix, Arizona, United States
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

ClinicalTrials.gov Identifier: NCT00445874     History of Changes
Other Study ID Numbers: 06-003-23
First Posted: March 9, 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
Conjunctivitis, Allergic
Drug Hypersensitivity
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Ketotifen
Anti-Allergic Agents
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs