* To assess the efficacy of R348 Ophthalmic Solutions administered for 12 weeks to subjects evaluated by objective and subjective measures. * To investigate the safety and tolerability of R348 Ophthalmic Solutions administered for 12 weeks to subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
35
R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day
Placebo Ophthalmic Solution 2 drops per eye twice a day
U. Miami - Bascom Palmer Eye Institute
Plantation, Florida, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
Change From Baseline (Visit 1) of Total Corneal Fluorescein Staining Score at 12 Weeks.
Change from baseline (Visit 1) of total CFS score at 12 weeks. Total CFS score range 0-20, where '0' represents no fluorescein staining of any region and '20' represents severe staining the entire cornea.
Time frame: Baseline to 12 weeks
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