Back to resultsEvaluation of Efficacy and Safety of an Anti-Allergy Drug With a Contact Lens in Allergic Conjunctivitis
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ketotifen with a Contact Lens (generic name not yet established)
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis focused on measuring allergic conjunctivitis, ophthalmology, multicenter, controlled
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Ocular itching
Secondary Outcome Measures
Conjunctival, ciliary, and episcleral redness; chemosis and mucous discharge; tearing and lid swelling
Full Information
NCT ID
NCT00432757
First Posted
February 4, 2007
Last Updated
April 8, 2009
Sponsor
Vistakon Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00432757
Brief Title
Evaluation of Efficacy and Safety of an Anti-Allergy Drug With a Contact Lens in Allergic Conjunctivitis
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 Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Vistakon Pharmaceuticals
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
Keywords
allergic conjunctivitis, ophthalmology, multicenter, controlled
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ketotifen with a Contact Lens (generic name not yet established)
Primary Outcome Measure Information:
Title
Ocular itching
Secondary Outcome Measure Information:
Title
Conjunctival, ciliary, and episcleral redness; chemosis and mucous discharge; tearing and lid swelling
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Pall, OD, MS, FAAO
Organizational Affiliation
Vistakon Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Los Angeles
State/Province
California
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Memphis
State/Province
Tennessee
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Efficacy and Safety of an Anti-Allergy Drug With a Contact Lens in Allergic Conjunctivitis
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