A Safety, Tolerability and Pharmacokinetics Study of R932348 Eye Drops in Patients With Dry Eye Disease

This is a randomized, double-blind, placebo-controlled single and multiple ascending dose
study to evaluate the ocular tolerability, safety, and pharmacokinetics of R348 administered
in patients with mild to moderate keratoconjunctivitis sicca (KCS).

Inclusion Criteria:

- Mild to moderate Keratoconjunctivitis Sicca.

- A corrected visual acuity in both eyes of 20/40 or better.

- An intraocular pressure of < 21 mm Hg with a difference between eyes of < 6 mm Hg.

Exclusion Criteria:

- History or evidence of ocular infection, inflammation, or conjunctivitis within 2
months prior to the first dosing day.

- History or evidence of blepharitis requiring the use of antibiotics or eye scrubs
within 2 months prior to the first dosing day.

- History of herpes simplex keratitis at any time.

- Current ocular allergy symptoms.

- Recent use of eye medications such as steroids or cyclosporine

- Refractive eye surgery within 12 months of the first dosing day.

- Other eye surgeries within 4 months of the first dosing day.

- Current use of contact lenses or discontinuation of contact lens use within 2 weeks
of the first dosing day.

- Receipt of any blood or blood products within 90 days prior to the first dosing day.

- Participation in any clinical study within 30 days prior to the first dosing day.

- History of disease, or currently have a significant illness or abnormal laboratory
finding as determined by your study doctor.

- Positive for hepatitis B, hepatitis C or HIV.

- Smoked regularly within 12 months of first dosing day.

- History of substance abuse, drug addiction or alcoholism.