To compare the efficacy of XDEMVY ophthalmic drop to its vehicle control for the treatment of Demodex blepharitis and its impact on the soft contact lens wearing experience.
This Phase 4 study is a prospective, multicenter, randomized, vehicle-controlled, double-masked, two-arm, parallel treatment clinical trial of participants who have Demodex blepharitis and are current daily wear soft contact lenses wearers. The primary outcome measure is the reduction of collarettes at Day 43. The secondary outcome measures are the reduction of eyelid margin erythema at Day 43; subject-reported comfortable contact lens daily wear time; and total contact lens wear time. Safety will be determined by assessing adverse effects related to study drug administration as well as evaluating any clinically significant changes from baseline in visual acuity and slit lamp biomicroscopy findings.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
145
XDEMVY (lotilaner ophthalmic solution) 0.25%, administered topically twice a day for approximately 43 days
Vehicle of XDEMVY administered topically twice a day for approximately 43 days
Site
Cave Creek, Arizona, United States
Site
Long Beach, California, United States
Vision Institute
Colorado Springs, Colorado, United States
Reduction of collarettes at Day 43
Change in collarette score at Day 43 compared to baseline, graded from 0 (0 to 2 lashes have collarettes per eyelid) to 4 ( 2/3 or more of lashes have collarettes per eyelid)
Time frame: 43 days
Reduction of eyelid margin erythema at Day 43
Change in eyelid margin erythema score at Day 43 compared to baseline, graded from 0 (normal) to 3 (severe)
Time frame: 43 days
Subject-reported comfortable daily wear time
Comfortable daily wear time in hours per day
Time frame: 43 days
Total contact lens wear time
Total daily wear time in hours per day
Time frame: 43 days
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Site
Delray Beach, Florida, United States
Site
Indianapolis, Indiana, United States
Site
Pittsburg, Kansas, United States
Site
Louisville, Kentucky, United States
Site
Edina, Minnesota, United States
Site
Shelby, North Carolina, United States
Site
Fargo, North Dakota, United States
...and 4 more locations