A Phase 4 interventional study of Lotilaner ophthalmic solution, 0.25% and Vehicle control in Demodex Blepharitis, sponsored by Tarsus Pharmaceuticals, Inc.. Completed at 14 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-07-02.
Sponsored by Tarsus Pharmaceuticals, Inc. · Phase 4, Interventional, and Treatment
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.
73 studies on the registry are indexed under Blepharitis; 9 are open to participants now.
This study's enrollment of 145 is above the median of 60 across 65 interventional studies indexed under Blepharitis.
Browse Blepharitis studies →Tarsus Pharmaceuticals, Inc. is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 3 (38%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
XDEMVY (lotilaner ophthalmic solution) 0.25%, administered topically twice a day for approximately 43 days
Drug: Lotilaner ophthalmic solution, 0.25%
Vehicle of XDEMVY ophthalmic solution, administered topically twice a day for approximately 43 days
Drug: Vehicle control
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
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Tarsus Pharmaceuticals, Inc.