A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3)

Inclusion Criteria:

- Patient-reported history of Dry Eye Disease in both eyes.

- Use of over the counter artificial tears within the past 30 days.

- A negative urine pregnancy test for females and willingness to use adequate birth
control throughout the study.

- Able and willing to comply with all study procedures.

Exclusion Criteria:

- Presence of an ocular condition that could affect the study parameters such as active
ocular infections, ocular inflammation, glaucoma, or diabetic retinopathy;.

- Unwilling to stop wearing contact lenses during the study.

- LASIK or other ocular surgical procedures within 12 months prior to or during the
study.

- Use of prohibited medications

- Significant medical conditions that could affect the study parameters.