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NCT00836485 Clinical Trial

Evaluation of the Safety and Efficacy of Ketotifen 4.0% Patch as Compared to Placebo Patch, Olopatadine 0.2% Ophthalmic Solution, and Artificial Tears in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis

Allergic Conjunctivitis Clinical Trial

Official title:
A Prospective, Multi-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of the Safety and Efficacy of Ketotifen 4.0% Patch as Compared to Placebo Patch, Olopatadine 0.2% Ophthalmic Solution, and Artificial Tears in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00836485
Other study ID # SNJ-ALK201/08-003-11
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 2009
Est. completion date March 2009

Study information
Verified date August 2023
Source Senju USA, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a phase 2 study that will consist of 4 visits over a 5 week period. Drug will be evaluated using the conjunctival allergen challenge model of allergic conjunctivitis.

Recruitment information / eligibility
Status Completed
Enrollment 122
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years of age of either sex and any race - positive history of ocular allergies and a positive skin test reaction to cat hair, cat dander, dog dander, grasses, ragweed, trees, dust mites, and/or cockroaches within the past 24 months - able and willing to avoid all disallowed medication for the washout period and during the study Exclusion Criteria: - active ocular infection or skin condition - ocular surgery within the past 3 months - pregnancy or nursing

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ketotifen 4.0% Patch
This investigational drug is a transdermal patch indicated to treat allergic conjunctivitis. Application is intended for overnight wear between 8-10 hours.
• Placebo
The control is a placebo patch that contains only the inactive ingredients of ketotifen.
• Olopatadine 0.2%
1 gtt/eye on two separate occasions
• Artificial tears
1 gtt/eye on two separate occasions

Locations
Country Name City State
United States Ora Andover Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Senju USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ocular itching and bulbar conjunctival redness Visit 3 and Visit 4
Secondary Ocular: Ciliary, episcleral, and inferior palpebral conjunctival redness; chemosis; lid swelling; tearing; ocular mucous discharge Visit 3 and Visit 4
Secondary Nasal: Rhinorrhea; ear or palate pruritis; nasal pruritis; nasal congestion; and a composite score of all nasal symptoms Visit 3 and Visit 4
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