Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients
Information source: Alcon Research
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dry Eye Disease
Intervention: Difluprednate 0.05% ophthalmic emulsion (Drug); Difluprednate vehicle (Other)
Phase: Phase 2
Status: Completed
Sponsored by: Alcon Research
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.
Clinical Details
Official title: A Multi-Center, Randomized, Double-Masked Evaluation of Anti-Inflammatory Treatment in Patients With Dry Eye
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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 and Contacts
Contact Alcon Call Center at 1-888-451-3937 for Trial Locations, Fort Worth, Texas 76134, United States
Additional Information
Starting date: February 2011
Last updated: March 8, 2013
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