AGN-229666 Ophthalmic Solution for the Treatment of Seasonal or Perennial Allergic Conjunctivitis

Phase 3CompletedNCT02082262

Allergan140 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Conjunctivitis, Allergic

Interventions

AGN-229666DRUG

One to two drops of AGN-229666 twice daily in each eye for 10 weeks.

Eligibility

Sex: ALLMin age: 10 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Japanese patients living in Japan with allergic conjunctivitis with itching and redness * Able and willing to discontinue wearing any contact lenses during the study period. Exclusion Criteria: * Eye surgical intervention and/or a history of refractive surgery within 6 months * History of retinal detachment, diabetic retinopathy, or progressive retinal disease * Presence of active eye infection (bacterial, viral, or fungal) * History of an eye herpetic infection * Use of corticosteroids within 6 months or anticipated use during the study.

Locations (1)

Unnamed facility

Tokyo, Japan

Outcomes

Primary Outcomes

Change From Baseline In Ocular Itching Frequency Score Using a 6-point Scale

Ocular itching frequency is assessed on a 6-poing scale, where 0 = did not occur, 1 = once in 3 days, 2 = twice in 3 days, 3 = once every day, 4 = 2 or more times every day, and 5 = virtually all the time over the past 3 days. Ocular itching frequency is evaluated over the 3 days prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.

Time frame: Baseline, Day 70

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.