The purpose of this study is to assess the safety and efficacy of MIM-D3 Ophthalmic Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry eye.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
403
1% MIM-D3 dosed BID
Vehicle dosed BID
MIM-725 Investigational Site
Waterbury, Connecticut, United States
MIM-725 Investigational Site
Lewiston, Maine, United States
MIM-725 Investigational Site
Andover, Massachusetts, United States
MIM-725 Investigational Site
Quincy, Massachusetts, United States
Corneal Fluorescein Staining
Time frame: Day 29
Ocular Dryness
Patient-derived, daily dryness symptoms for the 28 day time period will be be averaged to obtain a dryness score for the entire 28-day period. Average dryness scores over the 28-day treatment period will be compared between 1% MIM-D3 and placebo using t-tests.
Time frame: 28 Days
Total Ocular Fluorescein Staining
Time frame: Day 29
Ocular Discomfort
Patient-derived daily diary ocular discomfort symptoms for the 28 day time period will be averaged to obtain an ocular discomfort score for the entire 28-day period. Average ocular discomfort scores over the 28-day treatment period will be compared between 1% MIM-D3 and placebo using t-tests.
Time frame: 28 Days
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MIM-725 Investigational Site
Memphis, Tennessee, United States