Treatment of Ocular Demodex Infestation With Topical Ivermectin Cream 1%
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|ClinicalTrials.gov Identifier: NCT05213585|
Recruitment Status : Recruiting
First Posted : January 28, 2022
Last Update Posted : January 28, 2022
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|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.|
|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|
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.
- 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
- 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
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
|Contact: Craig J Helm, MDemail@example.com|
|Contact: Valerie Garcia, COTfirstname.lastname@example.org|