AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation

Alcon Research312 enrolled

Overview

The purpose of this study is to assess the safety and efficacy of AL-38583 in the treatment of the signs of inflammation associated with allergic conjunctivitis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

312

Conditions

Allergic Conjunctivitis

Interventions

AL-38583 ophthalmic solutionDRUG

AL-38583 ophthalmic solution vehicleDRUG

Inactive ingredients used as a placebo comparator

Dexamethasone ophthalmic suspension, 0.1%DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Presence of signs and symptoms of ocular inflammation in both eyes. * Have a positive CAC response at Visit 1. * Able to avoid the use of disallowed medications as well as contact lens wear for the specified period prior to Visit 1, and for the duration of the study. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Have known history or presence of persistent dry eye syndrome. * Presence of any ophthalmic abnormality that may affect the study outcomes. * Have a history of moderate to severe allergic asthma reaction to mountain cedar or the perennial allergens used in the study. * Other protocol-defined exclusion criteria may apply.

Outcomes

Primary Outcomes

Mean area under the curve 0-7 hours post-CAC for conjunctival redness scores

Time frame: Day 14

Secondary Outcomes

Mean daily diary ocular redness scores

Time frame: 2 week period between Day 0 and Day 14

Data from ClinicalTrials.gov

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