The purpose of this study is to determine the safety, tolerability and pharmacokinetics of R348 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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
R348 Ophthalmic Solution, 0.2% single and multiple ascending dose
R348 Ophthalmic Solution, 0.5%, single and multiple ascending dose
R348 Ophthalmic Solution, 1.0%, single and multiple ascending dose
Andover Eye Associates
Andover, Massachusetts, United States
Change in corneal fluorescein staining
Time frame: Baseline and Visits 4, 8 and 12
Change in conjunctival lissamine green staining
Time frame: Baseline and Visits 4, 8 and 12
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Placebo, single and multiple ascending dose