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

Senju Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Allergic Conjunctivitis

Treatments: Drug: Olopatadine 0.2%; Drug: Artificial tears; Drug: Placebo; Drug: Ketotifen 4.0% Patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT00836485

SNJ-ALK201/08-003-11

Details and patient eligibility

About

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.

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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122 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

Ketotifen 4.0% Patch

Treatment:

Drug: Ketotifen 4.0% Patch

2

Placebo Comparator group

Description:

Placebo Patch

Treatment:

Drug: Placebo

3

Active Comparator group

Description:

Pataday(TM)

Treatment:

Drug: Olopatadine 0.2%

4

Placebo Comparator group

Description:

Placebo eye drops

Treatment:

Drug: Artificial tears