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Treatment of Ocular Demodex Infestation With Topical Ivermectin Cream 1%

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05213585
Recruitment Status : Recruiting
First Posted : January 28, 2022
Last Update Posted : January 28, 2022
Sponsor:
Information provided by (Responsible Party):
Craig J. Helm, Helm Vision Group

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.

Condition or disease Intervention/treatment Phase
The Focus of the Study is to Assess the Effectiveness of Topical Ivermectin on Eliminating Eyelash Sleeves Drug: Ivermectin cream Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The untreated eye will be observed in parallel with the contralateral treated eye.
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Treatment of Ocular Demodex Infestation With Topical Ivermectin Cream 1%
Actual Study Start Date : August 24, 2021
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

Arm Intervention/treatment
Experimental: Treated eyes
All participants will have one eye randomly selected for treatment.
Drug: Ivermectin cream
Topical application of ivermectin cream to eyelashes of treatment eye.

No Intervention: Untreated eyes
No treatment will be given to the control eye.



Primary Outcome Measures :
  1. Comparative density of sleeves [ Time Frame: Each patient will be followed for 6 months. ]
    The density of sleeves will be clinically assessed and graded by the outcomes assessor


Secondary Outcome Measures :
  1. Comparative assessment of tear osmolarity between treated and untreated eyes [ Time Frame: Each patient will be followed for 6 months ]
    The tear osmolarity will be tested in each eye at each follow-up visit



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:Voluntary participation of subjects with moderate to dense sleeves with no allergy to ivermectin and the ability to keep follow-up appointments.

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Exclusion Criteria: Patients under 18 years old and those allergic to ivermectin.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05213585


Contacts
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Contact: Craig J Helm, MD 6617132575 craighelm@sbcglobal.net
Contact: Valerie Garcia, COT 661-259-3937 techmgr@helmvision.com

Locations
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United States, California
Helm Vision Group Recruiting
Santa Clarita, California, United States, 91355
Contact: Valerie M Garcia, COT    661-259-3937    techmgr@helmvision.com   
Contact: Maggie Hernandez    661-259-3937    maggieluna02@yahoo.com   
Sponsors and Collaborators
Helm Vision Group
Publications of Results:
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Responsible Party: Craig J. Helm, Physician, Helm Vision Group
ClinicalTrials.gov Identifier: NCT05213585    
Other Study ID Numbers: Pro00044340
First Posted: January 28, 2022    Key Record Dates
Last Update Posted: January 28, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no current plan to share data with other researchers, unless requested.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Parasitic Diseases
Infections
Ivermectin
Antiparasitic Agents
Anti-Infective Agents