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 Overview
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Brief Summary
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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
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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

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Drug: Ketotifen 4.0% Patch
* Drug: Placebo
* Drug: Olopatadine 0.2%
* Drug: Artificial tears


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Ketotifen 4.0% Patch | Drug: Ketotifen 4.0% Patch<br>* This investigational drug is a transdermal patch indicated to treat allergic conjunctivitis. Application is intended for overnight wear between 8-10 hours.<br>|
| Placebo Comparator: 2<br>Placebo Patch | Drug: Placebo<br>* The control is a placebo patch that contains only the inactive ingredients of ketotifen.<br>|
| Active Comparator: 3<br>Pataday(TM) | Drug: Olopatadine 0.2%<br>* 1 gtt/eye on two separate occasions<br>* Other names: Pataday(TM);|
| Placebo Comparator: 4<br>Placebo eye drops | Drug: Artificial tears<br>* 1 gtt/eye on two separate occasions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular itching and bulbar conjunctival redness |  | Visit 3 and Visit 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular: Ciliary, episcleral, and inferior palpebral conjunctival redness; chemosis; lid swelling; tearing; ocular mucous discharge |  | Visit 3 and Visit 4 | 
| Nasal: Rhinorrhea; ear or palate pruritis; nasal pruritis; nasal congestion; and a composite score of all nasal symptoms |  | Visit 3 and Visit 4 |