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NCT00445874 Clinical Trial

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

Allergic Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00445874
Other study ID # 06-003-23
Secondary ID
Status Completed
Phase Phase 3
First received March 7, 2007
Last updated April 8, 2009
Start date February 2007
Est. completion date May 2007

Study information
Verified date April 2009
Source Vistakon Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date May 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 8 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

Intervention

Drug:
• Ketotifen with a Contact Lens (no generic name)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Vistakon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ocular itching
Secondary Conjunctival, ciliary, and episcieral redness; chemosis and mucous discharge; tearing and lid swelling
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