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Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients

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ClinicalTrials.gov Identifier: NCT01276223
Recruitment Status : Completed
First Posted : January 13, 2011
Results First Posted : March 11, 2013
Last Update Posted : March 11, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dry Eye Disease Drug: Difluprednate 0.05% ophthalmic emulsion Other: Difluprednate vehicle Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 722 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Masked Evaluation of Anti-Inflammatory Treatment in Patients With Dry Eye
Study Start Date : February 2011
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
Drug: Difluprednate 0.05% ophthalmic emulsion
Topical ocular steroid
Other Name: DUREZOL™
Placebo Comparator: 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.
Other: Difluprednate vehicle
Inactive ingredients used as Run-In and placebo comparator

Primary Outcome Measures :
  1. Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks [ Time Frame: 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01276223

United States, Texas
Contact Alcon Call Center at 1-888-451-3937 for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01276223     History of Changes
Other Study ID Numbers: C-10-078
First Posted: January 13, 2011    Key Record Dates
Results First Posted: March 11, 2013
Last Update Posted: March 11, 2013
Last Verified: March 2013

Keywords provided by Alcon Research:
Dry eye
ocular discomfort

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs