Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients

Alcon Research722 enrolled

Overview

The purpose of this study was to determine if difluprednate ophthalmic emulsion is effective in reducing the ocular symptoms of dry eye disease, as measured by a global Visual Analog Scale (VAS) discomfort score.

Following Run-In, patients qualifying for treatment were randomized 1:1 to receive Durezol (experimental group) or Vehicle (control group) for 5 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

722

Conditions

Dry Eye Disease

Interventions

Difluprednate 0.05% ophthalmic emulsionDRUG

Topical ocular steroid

Difluprednate vehicleOTHER

Inactive ingredients used as Run-In and placebo comparator

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Normal subjects: * No known history of dry eye disease. * Non-contact lens wearer. * No current use of artificial tears or any other dry eye treatment. OR Dry eye patients: * At least a 6 month history of dry eye. * Non-contact lens wearer. * Uses artificial tears. * Experiences persistent ocular discomfort. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * The presence of any acute infectious or non-infectious ocular conditions in either eye within 1 month of Visit 1. * Severe Sjogren's Syndrome. * Lid function abnormalities. * Use of steroids, tetracycline, doxycycline, etc., within 30 days of Visit 1. * History of corneal surgery including refractive surgeries. * History of glaucoma or ocular hypertension * Other protocol-defined exclusion criteria may apply.

Locations (1)

Contact Alcon Call Center at 1-888-451-3937 for Trial Locations

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks

A Visual Analog Scale (VAS) was used by the subject to assess ocular discomfort, both frequency and severity, at baseline (pre-treatment) and weekly thereafter for 4 additional weeks. Each scale was 100 millimeters (mm) in length. The VAS score was calculated by measuring the length in mm from the start of the line to the intersection point of the vertical mark made by the subject. The Global Ocular Discomfort Score is a composite of the two VAS scores, ranging from 0 (very mildly) to 100 (very severely uncomfortable).

Time frame: Baseline, up to 4 weeks

Data from ClinicalTrials.gov

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