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Treatment of Ocular Demodex Infestation With Topical Ivermectin Cream 1%
Sponsor: Helm Vision Group
Summary
Patients with Demodex infestation of the eyelids will have the sleeves from both eyes cleaned off with microblepharoexfoliation. Afterwards, one eye will be randomly selected for treatment with topical ivermectin 1% cream. The treatment will be repeated on that eye 2 weeks later. Afterwards, participants will present monthly for photographs of the eyelashes. The photographs will be reviewed by an ophthalmologist outside of the study site who will be blind to which eye was treated and independently grade the amount of sleeves in each eye. The follow-up will be for 6 months after the second treatment for Group A eyes. At the 6 months point the second phase of the study will begin by treating the control eyes (now called Group B eyes) with a single application of ivermectin cream and no pre-treatment with microblepharoexfoliation.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2021-08-24
Completion Date
2023-12-31
Last Updated
2026-09-24
Healthy Volunteers
Yes
Interventions
Ivermectin 1% cream
Both Group A and Group B eyes (from same patient) will be treated with microblepharoexfoliation. Afterwards, eyes randomly selected by computer will be assigned to Group A treatment eyes and the fellow eyes will be assigned to Group B. Group A eyes will receive an application of topical ivermectin 1% cream to the eyelids. This will be repeated 2 weeks later. Group B eyes will not receive treatment and serve as controls. After 6 months, Group B eyes will receive a single application of ivermectin 1% cream without repeating the microblepharoexfoliation that was done 6 months earlier. Both Group A and Group B eyes will be followed for an additional 6 months with assessment visits at 9 months and 12 months.
Locations (1)
Helm Vision Group
Santa Clarita, California, United States