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

Condition(s) targeted: Allergic Conjunctivitis

Intervention: Ketotifen 4.0% Patch (Drug); Placebo (Drug); Olopatadine 0.2% (Drug); Artificial tears (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Senju USA, Inc.

Official(s) and/or principal investigator(s):
Gail Torkildsen, MD, Principal Investigator, Affiliation: ORA, Inc.
TBD TBD, Principal Investigator, Affiliation: TBD

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Ocular itching and bulbar conjunctival redness

Secondary outcome:

Ocular: Ciliary, episcleral, and inferior palpebral conjunctival redness; chemosis; lid swelling; tearing; ocular mucous discharge

Nasal: Rhinorrhea; ear or palate pruritis; nasal pruritis; nasal congestion; and a composite score of all nasal symptoms

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Ora, Andover, Massachusetts 01810, United States

Starting date: February 2009
Last updated: May 15, 2009