The purpose of this study is to determine whether 0.2% and 0.5% R348 Ophthalmic Solutions are safe and effective in the treatment of Patients with Keratoconjunctivitis Sicca.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
204
R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks.
R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks.
Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks.
Sall Research Medical Center
Artesia, California, United States
North Bay Eye
Change of Corneal Fluorescein Staining of the Inferior Cornea Region.
Change from baseline (Visit 3) of inferior region CFS score at 12 weeks. Inferior region CFS score range 0-4, where '0' represents no fluorescein staining and '4' represents severe staining on the cornea.
Time frame: Baseline to Week 12
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