Dry Eye Study

STUDY BASICS

Do you have symptoms of dry eye (dryness, burning, itching, irritation)? You may be able to take part in a research study to help find out if an eye drop containing an investigational medication can relieve dry eye symptoms. Compensation provided.

STUDY PURPOSE

Dry eye is a common condition that can lead to eye discomfort. Symptoms of dry eye can include dryness, burning, itching, irritation, grittiness, tearing, the feeling that you have something in your eye, and trouble focusing after using the computer or reading. Inflammation (swelling) of the surface of the eye may also occur with dry eye. Inflammation of the eye is sometimes treated with eye drops that contain a topical steroid, which is a medication used to reduce inflammation. The purpose of this study is to find out if an eye drop containing an investigational drug, named KPI-121, can provide relief from dry eye symptoms. The eye drops being used in this study contain a topical steroid medication called loteprednol etablonate which has been approved by the FDA. KPI-121 also contains mucus-penetrating particles (MPPs) that help get the drug through the tear film and keep the drug in the eye longer. Researchers hope this combination will reduce the amount of drug needed, and/or reduce the number of times people need to use the drug.

COULD THIS STUDY BE RIGHT FOR YOU?

• Age 18 and up
• Have symptoms of dry eye (dryness, irritation, grittiness, burning)
• Willing to stop using eye drops during study
• Willing to stop wearing contact lenses during study

WHAT PARTICIPANTS CAN EXPECT

Participants will have 4 study visits, and will use eye drops for about 28 days. During the initial 3 hour visit, you will complete questionnaires, provide a medical history, and have several eye exams. Women may also have a urine pregnancy test. Qualified participants will put one dose of eye drops in each eye, and will be asked to repeat this 3 times at home. The drops will need to be administered 4 times per day for approximately 14 days. You will also be asked to keep a paper diary and answer questionnaires at home. During the second visit, you will complete additional questionnaires and assessments, and will have photographs taken of your eyes. Participants who continue to qualify for this study after these assessments will be randomly assigned (like the flip of a coin) to receive either eye drops containing the investigational medication, or eye drops containing placebo. The placebo looks and feels just like the investigational medication but does not contain any active drug. This visit will take about 2 hours. The drops will need to be administered 4 times per day for approximately 15 days. The third visit will last about an hour, and will include questionnaires and a review of your diary. Visit 4 will last about 2 hours, and will include questionnaires, the collection of diary information, eye exams and photographs, and a urine pregnancy test for some women.