To Evaluate the Efficacy of AL-38583 in the Reduction of Tear Eosinophil Count Following Conjunctival Allergen Challenge

Alcon Research

Overview

The purpose of the study is to determine whether Al38583 Ophthalmic Solution is safe and effective in reducing tear eosinophil levels at 5-8 hours after Conjunctival Allergen Challenge (CAC).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Allergic Conjunctivitis

Interventions

AL38583 Ophthalmic SolutionDRUG

Topical ophthalmic

MaxidexDRUG

Topical ophthalmic

VehicleDRUG

AL38583 Vehicle

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Have a positive bilateral CAC reaction (\>2 itching and \> conjunctival redness) to cat hair, cat dander, dust mites, cockroaches and/or dog dander within 10 minutes of instillation of the last titration of allergen at Visit 1 Exclusion Criteria: * Have a known allergy to the study medication(s) or their components (ex., dexamethasone, benzalkonium chloride)

Outcomes

Primary Outcomes

The primary efficacy variable is mean change in tear eosinophil level at Visit 7 post-CAC from Visit 2 post-CAC.

Time frame: 15 days

Secondary Outcomes

Mean change in relative ratio of tear eosinophil and neutrophils at Visit 7 post-CAC from Visit 2 post-CAC

Time frame: 15 days

Data from ClinicalTrials.gov

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