Summary:
Clinical Research Study for Adults with Dry Eye Disease
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. The disease most commonly affects women and people older than age 50.
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.
What is the OPUS-3 study?
The OPUS-3 clinical research study is testing an investigational eye drop solution 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 if the investigational eye drop is effective compared to an eye drop with no medicine in it, called a placebo eye drop. Participants in the study will be randomly assigned to receive either the investigational eye drop or placebo eye drop.
What is the investigational eye drop?
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.
SHP606 is an investigational anti-inflammatory eye drop that may help stop this inflammatory response, allowing damaged tissues to heal and decreasing the symptoms that accompany dry eye.
Who can participate?
The OPUS-3 study is for adults who have dry eye disease and who are trying to manage the symptoms of dry eye disease.
You may be eligible to participate in the OPUS-3 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 30 days
- Are willing to stop using artificial tear substitute during the study
- Do not have other eye conditions such as glaucoma, disease of the glands of the eye, or damage to the eye due to diabetes
What will happen during the OPUS-3 study?
If you are eligible for the study and agree to take part, your participation may last approximately four months. During the study, you will need to attend five study visits.
All study participants will receive the investigational eye drops and study-related tests and procedures at no charge. Participants will receive payment for their time and expenses.