Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients

A Multi-Center, Randomized, Double-Masked Evaluation of Anti-Inflammatory Treatment in Patients With Dry Eye

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.

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

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.