Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1)

Inclusion Criteria:

- Willing and able to read, sign, and date the informed consent and HIPAA documents

- Willing and able to comply with all study procedures

- Be at least 18 years of age

- Patient-reported history of dry eye in both eyes

- Demonstrate a positive response when exposed to the Controlled Adverse Environment
model

- A negative urine pregnancy test if female of childbearing potential and must use
adequate birth control throughout the study period

Exclusion Criteria:

- Any ocular condition that, in the opinion of the Investigator, could affect study
parameters including, but not limited to, active ocular infection, ocular
inflammation, glaucoma, and/or diabetic retinopathy

- Unwilling to avoid wearing contact lenses for 7 days prior to and for duration of the
study period

- Any blood donation or significant loss of blood within 56 days of Visit 1

- Any history of immunodeficiency disorder, positive HIV, hepatitis B, C, or evidence of
acute active hepatitis A (anti-HAV IgM), or organ or bone marrow transplant.

- Use of any topical ophthalmic preparations (including artificial tear substitutes) 72
hrs prior to Visit 1 and during the study

- Any significant chronic illness that could interfere with study parameters

- History of laser‑assisted in situ keratomileusis (LASIK) or similar type of corneal
refractive surgery within 12 months prior to Visit 1, and/or any other ocular surgical
procedure within 12 months prior to Visit 1; or any scheduled ocular surgical
procedure during the study period.

- Known history of alcohol and/or drug abuse

- Subjects with Dry eye secondary to scarring or destruction of conjunctival goblet
cells (as with Vitamin A deficiency)