A Phase 2 interventional study of Vehicle of TP-03 in Meibomian Gland Dysfunction, Demodex Infestation of Eyelid and Blepharitis, sponsored by Tarsus Pharmaceuticals, Inc.. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-09.
Sponsored by Tarsus Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate and compare the effect of two dosing regimens, BID versus TID dosing, of an Exploratory Vehicle (EV) on meibomian gland dysfunction (MGD) in patients with Demodex lid infestation.
This is a prospective, randomized controlled, three-arm, investigator- and interpreter-masked study. This study is intended to compare the effect of two dosing regimens of an exploratory vehicle on meibomian gland dysfunction (MGD) in participants with Demodex lid infestation. Approximately 12 participants will be enrolled in each arm. The administration period will last for approximately 85 days.
172 studies on the registry are indexed under Meibomian Gland Dysfunction; 23 are open to participants now.
This study's planned enrollment of 36 is below the median of 50 across 138 interventional studies indexed under Meibomian Gland Dysfunction.
Browse Meibomian Gland Dysfunction 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.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key 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.
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.
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.
Participants who were previously enrolled, dosed, and completed approximately 43 days of TID EV administration. Participants are crossed over to receive BID administration of EV for approximately 43 additional days.
Drug: Vehicle of TP-03
Participants are randomized to receive BID administration of EV for approximately 85 days.
Drug: Vehicle of TP-03
Participants are randomized to receive TID administration of EV for approximately 85 days
Drug: Vehicle of TP-03
The Exploratory Vehicle is the vehicle of TP-03 (lotilaner ophthalmic solution, 0.25%)
Also known as: Exploratory Vehicle
Treatment Emergent Adverse Events (TEAEs)
TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term. TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term.
Time frame: 85 days
Change from baseline in lower lid meibomian gland secretion score
For each of the 15 glands expressed, secretion characteristics will be graded via slit lamp examination on a scale of 0 to 3 (3=clear liquid secretion; 2=cloudy liquid secretion; 1=granularly opaque liquid secretion to inspissated/toothpaste consistency; and 0=no secretion).
Time frame: 85 days
Change from baseline in lid margin erythema.
Erythema of the eyelid margin will be assessed via slit lamp examination and graded on a scale of 0 (normal) to 3 (severe) for the upper and lower eyelids of each eye.
Time frame: 85 days
Change from baseline in tear breakup time assessed via slit lamp
Tear breakup time will be assessed via slit lamp examination and timed in seconds to two significant digits.
Time frame: 85 days
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Tarsus Pharmaceuticals, Inc.