- Males and females aged 18 years or older at time of consent
- Diagnosis of dry eye disease, characterized by subjective symptoms of dry eye for at
least 6 months, Schirmer test without anesthesia: =>1 mm and =
fluorescein staining score of =>4 (NEI Scale), and subject grading total score of =>
23 on the OSDI
- Planned initiation of, or changes to, concomitant medication that could affect dry eye
within 30 days of the Screening visit or during study
- Ocular disorders that may confound interpretation of study results such as significant
corneal surface disease not caused by dry eyes, abnormal corneal sensitivity, abnormal
tear spreading, including but not limited to the following: abnormal lid function, lid
position, or blink rate, that in the opinion of the investigator is clinically
significant, history of herpetic keratopathy
- Lacrimal punctal occlusion (plugs or cautery) within 2 months of the Screening visit
- Contact lens wear within 2 weeks of the Screening visit and/or during study
participation.