Phase 2 Trial of Experimental Eye Drops in the Treatment of the Signs and Symptoms of Moderate to Severe Dry Eye

Study Summary

The University of Chicago and Dr. Saidel are conducting a study to look at the safety and effectiveness of an experimental eye drops in the treatment of the signs and symptoms of moderate to severe dry eye. The study drug has been approved by the Food and Drug Administration as a cream to treat inflammation of the skin, but not for use in the eye, as is intended in this study.

You may be eligible to participate in this research study if you have been diagnosed with moderate to severe dry eye and have been using prescription and/or non-prescription medication for at least three months for the treatment of moderate to severe dry eye.

If you qualify and agree to participate, you will be assigned randomly by chance (similar to tossing a coin) to one of four study groups. You will be asked to come to the study site at least six times over 28 weeks. Each visit should take approximately one to two hours. You will be asked to apply the eye drops related to the study twice a day (every 12 hours or as close to every 12 hours as possible). At some time during the study you will receive placebo. A placebo is a compound which is meant to do nothing at all. The placebo is used to make sure that the changes you report are just not happening by chance. You will not be permitted to wear contact lenses and will not be allowed to use tanning devices or allowed excessive sunbathing for the duration of the study.

You may receive no benefit from participating in this study. However, knowledge gained from this study may help in the future treatment of people with dry eyes.

Participation Details

To be considered for enrollment into the study, you must:

• Be at least 18 years of age
• Give written informed consent
• Have the signs and symptoms of moderate to severe dry eye
• Be available for study visits for the duration of the study
• Meet study eligibility criteria as evaluated by Dr. Rao
• Understand the study instructions and be able to follow the study instructions

Study Director: Michael Saidel, MD
Department: Ophthalmology
For more information contact:
Rose Arrieta, RN
rarrieta@surgery.bsd.uchicago.edu
(773) 834-7964

IRB# 13659A