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.
Sponsor:
Information provided by:
Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00445874
First received: March 7, 2007
Last updated: April 8, 2009
Last verified: April 2009
  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 3

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
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 August 28, 2014