Why are the studies being done?

The SONATA and OPUS-2 clinical research studies are being done to test 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 to be used as a treatment for dry eye. 

The main purpose of the SONATA study is to see if the investigational eye drop is safe to use over a long period of time 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.       

The main purpose of the OPUS-2 study is to see if the investigational eye drop is effective and works to relieve and manage the symptoms of dry eye.

What is dry eye disease?

Dry eye is a common and often chronic 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. 

Symptoms of dry eye include:

• Stinging, burning, or scratchy feelings in your eyes


• A feeling like there’s something in your eye


• Eye dryness


• Eye discomfort


• Eye redness


• Sensitivity to light


• Periods of a lot of tearing


• Blurred vision

The symptoms of dry eye are different for everyone, and as the day goes on, these symptoms may often worsen. Your symptoms may range from mild eye discomfort to serious pain—all of which may impact your
vision and daily life.

How does the investigational eye drop work?

In patients with dry eye disease, certain conditions (dry environments) or situations (computer overuse, hormonal imbalances) may cause inflammation, resulting in damage to eye 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 (eye) tissues to heal and decreasing the symptoms that accompany dry eye. 

What will happen during the study?

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

What are the potential risks and benefits?

The study doctor will explain the study details and the potential risks and benefits of participating in the study. You may or may not benefit from being in the study. The information learned from the study and your participation may help improve treatment options for people with dry eye disease in the future. 

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