Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients

Phase 2

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: Difluprednate 0.05% ophthalmic emulsion; Other: Difluprednate vehicle

• Registration Number: NCT01276223
• Lead Sponsor: Alcon Research

Brief Summary

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

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-01-11
• Study First Submitted QC: 2011-01-12
• Study First Posted: 2011-01-13
• Study Start: 2011-02
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Results First Submitted: 2013-01-31
• Status Verified: 2013-03
• Results First Submitted QC: 2013-03-08
• Last Update Submitted: 2013-03-08
• Results First Posted: 2013-03-11
• Last Update Posted: 2013-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 722

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Durezol	Difluprednate 0.05% ophthalmic emulsion	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.
Vehicle	Difluprednate vehicle	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.

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks	Baseline, up to 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).

Trial Locations

Locations (1)

Contact Alcon Call Center at 1-888-451-3937 for Trial Locations; 🇺🇸 Fort Worth, Texas, United States