Safety and Efficacy Study of a Eye Drop for Eye Allergy

Phase 3CompletedNCT00889330

Vistakon Pharmaceuticals60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Allergic Conjunctivitis

Interventions

alcaftadineDRUG

0.25% Ophthalmic Solution, one drop in each eye at each of two visits.

PlaceboDRUG

Vehicle without active, one drop in each eye at each of two visits.

Eligibility

Sex: ALLMin age: 10 Years

Medical Language ↔ Plain English

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

Locations (2)

Unnamed facility

Fairfield, Ohio, United States

Unnamed facility

Mason, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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"

Time frame: 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

Time frame: Visit 4 (Day 14) At 20 minutes following Allergen Challenge

Data from ClinicalTrials.gov

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