Treatment of Ocular Demodex Infestation With Topical Ivermectin Cream 1%
1 other identifier
interventional
20
1 country
1
Brief 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, the patients will present monthly for photographs of the eyelashes. The photographs will be reviewed by an ophthalmologist outside of our institution 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 24, 2021
CompletedFirst Submitted
Initial submission to the registry
January 20, 2022
CompletedFirst Posted
Study publicly available on registry
January 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedJanuary 28, 2022
January 1, 2022
9 months
January 20, 2022
January 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Comparative density of sleeves
The density of sleeves will be clinically assessed and graded by the outcomes assessor
Each patient will be followed for 6 months.
Secondary Outcomes (1)
Comparative assessment of tear osmolarity between treated and untreated eyes
Each patient will be followed for 6 months
Study Arms (2)
Treated eyes
EXPERIMENTALAll participants will have one eye randomly selected for treatment.
Untreated eyes
NO INTERVENTIONNo treatment will be given to the control eye.
Interventions
Topical application of ivermectin cream to eyelashes of treatment eye.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Helm Vision Group
Santa Clarita, California, 91355, United States
Related Publications (1)
Choi Y, Eom Y, Yoon EG, Song JS, Kim IH, Kim HM. Efficacy of Topical Ivermectin 1% in the Treatment of Demodex Blepharitis. Cornea. 2022 Apr 1;41(4):427-434. doi: 10.1097/ICO.0000000000002802.
PMID: 34173370RESULT
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The outcomes assessor is blind to which eye was treated. This is a single arm study in that only 1 treatment protocol is being tested in one eye and the contralateral eye is being used as the control. Masking of the outcomes assessor is being done to eliminate bias from the treating physician.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician
Study Record Dates
First Submitted
January 20, 2022
First Posted
January 28, 2022
Study Start
August 24, 2021
Primary Completion
May 30, 2022
Study Completion
December 31, 2022
Last Updated
January 28, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share
There is no current plan to share data with other researchers, unless requested.