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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

Page last updated: August 20, 2015

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