Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients

Study Overview
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Brief Summary
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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.

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

Official Title
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A Multi-Center, Randomized, Double-Masked Evaluation of Anti-Inflammatory Treatment in Patients With Dry Eye

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: Difluprednate 0.05% ophthalmic emulsion
* Other: Difluprednate vehicle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Durezol<br>Difluprednate 0.05% ophthalmic emulsion, 1 drop to the study eye 2 times a day for 4 weeks, followed by 1 drop to the study eye once daily for 1 week to allow for tapering of the steroid exposure. | Drug: Difluprednate 0.05% ophthalmic emulsion<br>* Topical ocular steroid<br>* Other names: DUREZOL™;|
| Placebo Comparator: Vehicle<br>Difluprednate vehicle, 1 drop to the study eye 2 times a day for 4 weeks, followed by 1 drop to the study eye once daily for 1 week. | Other: Difluprednate vehicle<br>* Inactive ingredients used as Run-In and placebo comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline, up to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry eye, ocular discomfort