Clinical Trial 16771

Rockville Centre, NY 11570

Study Summary:

If your eyes feel dry and irritated all the time, you’re not alone. More than 25 million Americans are affected by dry eye disease.

What is dry eye disease?

Dry eye is a common eye condition that results in decreased quantity of tears or poor quality of tears. Several things may cause dry eye, such as hormonal changes caused by aging, living in a place with low humidity, side effects from medications, or staring at a computer screen for long periods of time.

About the study

The SONATA clinical research study is testing an investigational eye drop solution, called lifitegrast, as a potential new type of treatment for people with dry eye disease. “Investigational” means that the United States Food and Drug Administration (FDA) has not approved lifitegrast for use in the United States.

The main purpose of this study is to see how safe the investigational eye drop is compared to an eye drop with no medicine in it. This is called a placebo eye drop. Participants in the study will randomly be assigned to receive either the investigational eye drop or placebo eye drop.

About the study drug

In patients with dry eye disease, certain conditions (dry environments) or situations (computer overuse, hormonal imbalances) may cause inflammation, resulting in damage to ocular tissues and feelings of dry, irritated, burning, and stinging eyes.

Lifitegrast is an investigational anti-inflammatory eye drop that may help stop this inflammatory response, allowing damaged ocular tissues to heal and decreasing the symptoms that accompany dry eye.

Who can participate?

The SONATA study is for men and women who have dry eye disease and who are trying to manage symptoms such as eye dryness, irritation, discomfort, and blurry vision.

You may be eligible to participate in the SONATA study if you:

  • Are at least 18 years old
  • Have dry eye symptoms in both eyes
  • Have used an artificial tear substitute within the past 60 days
  • Do not have other eye conditions such as increased pressure in the eye (glaucoma), disease of the glands of the eye, or damage to the eye due to diabetes

What does the study involve?

The study may last for up to a year. During the study, there will be between five and seven study visits.

All study participants will receive the study drugs and study-related tests, procedures, and devices at no charge. Participants will receive payment for their time and expenses.

Where are the studies taking place?

Click here for a list of study locations.

For more information or to find out if you qualify, visit Sonata Research Study.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.