An Open-Label, Long-Term Study With AL-4943A Ophthalmic Solution, 0.2% in Patients With Allergic Conjunctivitis

Alcon Research110 enrolled

Overview

The objective of this study is to assess safety and efficacy of long-term use of AL-4943A (Olopatadine Hydrochloride Ophthalmic Solution, 0.2%) in patients with allergic conjunctivitis.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

Allergic Conjunctivitis

Interventions

Olopatadine Hydrochloride Ophthalmic Solution, 0.2%DRUG

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects must provide written consent. * Subjects must have a diagnosis of allergic conjunctivitis. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Itching and/or hyperemia associated with diseases other than allergic conjunctivitis. * Retinal detachment, diabetic retinopathy, or any progressive disease in posterior segment of the eye. * Known history of ocular infection. * Contact lens wear during study. * Pregnant, nursing. * Participation in another clinical study within 30 days of Informed Consent. * Other protocol-defined exclusion criteria may apply.

Locations (1)

Investigational Center

Osaka, Osaka, Japan

Outcomes

Primary Outcomes

Mean Itching Score by Visit

Ocular itching will be assessed by the subject and graded on a 6-point scale, where 0=did not occur and 5=virtually all the time over the past 3 days.

Time frame: Up to Week 10

Mean Total Hyperemia Score by Visit

Ocular hyperemia (redness) will be assessed by the investigator. Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctival scores.

Time frame: Up to Week 10

Secondary Outcomes

Mean Subjective Symptoms by Visit

Time frame: Up to Week 10

Data from ClinicalTrials.gov

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