Safety and Efficacy Study of a Eye Drop for Eye Allergy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of an anti-allergy eyedrop.

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Drug: alcaftadine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 10 years of age positive history of ocular allergies positive skin test reaction to allergens. Exclusion Criteria: known allergy, contraindication, or sensitivities to the use of any of the study medication(s) or their components ocular surgical intervention within three (3) months prior to visit 1 or during the study known history of retinal detachment, diabetic retinopathy, or progressive retinal disease, or glaucoma any other significant illness

Ages Eligible for Study
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Minimum Age: 10 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: alcaftadine ophthalmic solution<br>active treatment: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14). | Drug: alcaftadine<br>* 0.25% Ophthalmic Solution, one drop in each eye at each of two visits.<br>|
| Placebo Comparator: inactive ophthalmic solution vehicle<br>Placebo, vehicle: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14). | Drug: Placebo<br>* Vehicle without active, one drop in each eye at each of two visits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation. | A 0 to 4 scale used, allowing for half increment scores, where 0 indicates none and 4 indicates incapacitating itch with an irresistible urge to rub; measurement taken at up to 7 minutes following allergen challenge, 16 hours post treatment instillation. | Visit 3 (Day 0) 16 hours post-dose, at up to 7 minutes following Allergen Challenge | 
| Conjunctival Redness at Visit 3 (Day 0) at 20 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation | A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates none and 4 indicates extremely red; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation. | Visit 3 (Day 0) At 20 minutes following Allergen Challenge, 16 hours post-treatment | 
| Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation | 0 to 4 scale, allowing for half increment scores, where 0 indicates none and 4 indicates incapacitating itch with an irresistible urge to rub | Visit 4 (Day 14) up to 7 minutes following Allergen Challenge | 
| Conjunctival Redness at Visit 4 (Day 14) at 20 Minutes Following Allergen Challenge, 15 Minutes Post Treatment Instillation | A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates none and 4 indicates extremely red; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation. | Visit 4 (Day 14) At 20 minutes following Allergen Challenge |