Evaluation of Efficacy and Safety of an Anti-Allergy Drug With a Contact Lens in the Treatment of Allergic Conjunctivitis
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
1 other identifier
interventional
120
1 country
7
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2007
Shorter than P25 for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 7, 2007
CompletedFirst Posted
Study publicly available on registry
March 9, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedApril 9, 2009
April 1, 2009
March 7, 2007
April 8, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ocular itching
Secondary Outcomes (1)
Conjunctival, ciliary, and episcieral redness; chemosis and mucous discharge; tearing and lid swelling
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Active ocular infection
- Clinically significant blepharitis
- Follicular conjunctivitis
- Pterygium
- Narrow angle glaucoma
- Dry eye dyndrome
- Ocular surgery within past 6 months
- Pregnancy or lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Unknown Facility
Phoenix, Arizona, 85032, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Irvine, California, United States
Unknown Facility
North Andover, Massachusetts, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Fairfield, Ohio, United States
Unknown Facility
Mason, Ohio, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Brian Pall, OD, MS, FAAO
Vistakon Pharmaceutical
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 7, 2007
First Posted
March 9, 2007
Study Start
February 1, 2007
Study Completion
May 1, 2007
Last Updated
April 9, 2009
Record last verified: 2009-04