Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

722 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-01-31

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.

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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.

Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Durezol

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.

Group Type EXPERIMENTAL

Difluprednate 0.05% ophthalmic emulsion

Intervention Type DRUG

Topical ocular steroid

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.

Group Type PLACEBO_COMPARATOR

Difluprednate vehicle

Intervention Type OTHER

Inactive ingredients used as Run-In and placebo comparator

Interventions

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Difluprednate 0.05% ophthalmic emulsion

Topical ocular steroid

Intervention Type DRUG

Difluprednate vehicle

Inactive ingredients used as Run-In and placebo comparator

Intervention Type OTHER

Other Intervention Names

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DUREZOL™

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.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes