Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alcon Research
• Treatments: Anti-Inflammatory Agents; Difluprednate; Fluprednisolone

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.