AGN-229666 for the Treatment of Allergic Conjunctivitis

Phase 2CompletedNCT01754766

Allergan90 enrolled

Overview

This study will evaluate the safety and efficacy of AGN-229666 for the treatment of allergic conjunctivitis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Allergic Conjunctivitis

Interventions

AGN-229666DRUG

One drop of AGN-229666 into each eye on Day 1 and Day 15.

vehicle of AGN-229666OTHER

One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Japanese patients living in Japan with a history of allergic conjunctivitis * Willing to discontinue wearing contact lenses during the study period Exclusion Criteria: * Use of nicotine products during the study period * Presence of active eye infection (bacterial, viral, or fungal) * History of an ocular herpetic infection * Eye surgery intervention within 3 months and/or a history of refractive surgery within the past 6 months

Locations (1)

Unnamed facility

Tokyo, Japan

Outcomes

Primary Outcomes

Ocular Itching Score at Day 1

The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (CAC) (8 hours post-dose) at Day 1 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes.

Time frame: Day 1

Secondary Outcomes

Ocular Itching Score at Day 15

The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (16 hours post-dose) at Day 15 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes.

Time frame: Day 15

Conjunctival Hyperemia Score

Conjunctival hyperemia is the engorgement of the blood vessels (redness) of the clear membrane covering the white surface of the eye. Conjunctival hyperemia was evaluated 15 minutes post conjunctival allergen challenge (CAC) (8 hours post dose) on Day 1 for both eyes using a 9-point scale in half-unit increments where: 0=none to 4=Extremely severe. The score for each participant was the average of the score of both eyes.

Time frame: Day 1

Data from ClinicalTrials.gov

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