A Phase 2 interventional study of TP-03 and TP-03 Vehicle in Meibomian Gland Dysfunction, Blepharitis and Demodex Infestation, sponsored by Tarsus Pharmaceuticals, Inc.. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by Tarsus Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
The purpose of this study is to compare the safety and efficacy of TP-03, 0.25%, an eyedrop, BID vs TID dosing regimens for the treatment of meibomian gland dysfunction in patients with Demodex lid infestation.
This Phase 2a study is a randomized, two-arm, double-masked, multicenter, parallel pilot study to compare the safety and efficacy of two dosing regimens of TP-03, BID vs TID, for the treatment of meibomian gland dysfunction in patients with Demodex lid infestation. The primary objective of the study is to assess the safety and efficacy of two dosing regimens of TP-03, 0.25% from Day 1 to Day 85 in adult participants with meibomian gland dysfunction in the presence of Demodex infestation. Efficacy will be determined by assessing lower lid meibomian gland secretion, lid margin erythema, bulbar redness, tear breakup time, ocular surface staining, and dry eye symptoms. Safety will be determined by assessing adverse effects related to the treatment as well as evaluating any changes in visual acuity and slit lamp biomicroscopy from baseline.
172 studies on the registry are indexed under Meibomian Gland Dysfunction; 23 are open to participants now.
This study's enrollment of 39 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.
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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.
TP-03, lotilaner ophthalmic solution, 0.25% administered topically twice a day and TP-03 vehicle administered once a day to maintain masking for approximately 85 days
Drug: TP-03 · Drug: TP-03 Vehicle
TP-03, lotilaner ophthalmic solution, 0.25% administered topically three times a day for approximately 85 days
Drug: TP-03
TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day in participants in the BID dosing arm and three times a day in participants in the TID dosing arm
Vehicle of TP-03 ophthalmic solution, administered once a day in participants in the BID dosing arm to maintain masking between arms
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Number of participants with 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 at Day 85
For each of the 15 glands expressed, meibomian gland secretion characteristics were graded via slit lamp examination on a scale of 0 to 3 (0=worst, 3=best). Total meibomian gland secretion score is the sum of the grades for all 15 glands with a range from 0 to 45
Time frame: Day 85 visit
Change From Baseline in Lid Margin Erythema (Upper Eyelid) at Day 85
Erythema of the eyelid margin was assessed via slit lamp examination and graded on a scale of 0 (normal) to 3 (severe).
Time frame: Day 85 visit
| Milestone | BID Dosing | TID Dosing |
|---|---|---|
| Started | 21 | 18 |
| Completed | 20 | 18 |
| Not completed | 1 | 0 |
Number of participants with TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term.
| Participants | BID Dosing | TID Dosing |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 1 | 1 |
For each of the 15 glands expressed, meibomian gland secretion characteristics were graded via slit lamp examination on a scale of 0 to 3 (0=worst, 3=best). Total meibomian gland secretion score is the sum of the grades for all 15 glands with a range from 0 to 45
| score on a scale | BID Dosing | TID Dosing |
|---|---|---|
| Change From Baseline in Lower Lid Meibomian Gland Secretion Score at Day 85 | 10.5 ± 6.94 | 11.7 ± 7.89 |
Erythema of the eyelid margin was assessed via slit lamp examination and graded on a scale of 0 (normal) to 3 (severe).
| score on a scale | BID Dosing | TID Dosing |
|---|---|---|
| Change From Baseline in Lid Margin Erythema (Upper Eyelid) at Day 85 | -1.1 ± 0.85 | -1.0 ± 0.59 |
Collected over 200 days. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BID Dosing | 0/21 (0%) | 1/21 (4.8%) | 8/21 (38.1%) |
| TID Dosing | 0/18 (0%) | 0/18 (0%) | 1/18 (5.6%) |
| Event | BID Dosing | TID Dosing |
|---|---|---|
| PresyncopeNervous system disorders | 1/21 | 0/18 |
| Event | BID Dosing | TID Dosing |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 2/21 | 0/18 |
| ConjunctivitisInfections and infestations | 1/21 | 1/18 |
| Ocular discomfortEye disorders | 1/21 | 0/18 |
| ConjunctivochalasisEye disorders | 1/21 | 0/18 |
| Vitreous floatersEye disorders | 1/21 | 0/18 |
| Gastroesophageal reflux diseaseGastrointestinal disorders | 1/21 | 0/18 |
| BronchitisInfections and infestations | 1/21 | 0/18 |
| COVID-19Infections and infestations | 1/21 | 0/18 |
| Gastroenteritis viralInfections and infestations | 1/21 | 0/18 |
| HordeolumInfections and infestations | 1/21 | 0/18 |
| Age, Continuous(years) | BID Dosing | TID Dosing | Total |
|---|---|---|---|
| Mean | 61.2 ± 15.74 | 66.6 ± 13.13 | 63.7 ± 14.66 |
| Sex: Female, Male(Participants) | BID Dosing | TID Dosing | Total |
|---|---|---|---|
| Female | 12 | 11 | 23 |
| Male | 9 | 7 | 16 |
| Ethnicity (NIH/OMB)(Participants) | BID Dosing | TID Dosing | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 2 | 4 |
| Not Hispanic or Latino | 19 | 16 | 35 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | BID Dosing | TID Dosing | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 |
| White | 18 | 15 | 33 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | BID Dosing | TID Dosing | Total |
|---|---|---|---|
| United States | 21 | 18 | 39 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2022 to primary completion in May 2023, 9 months.
Results were first posted in Oct 2025, 2 years 4 months after primary completion.
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Studies of the drug tested here: TP-03
Tarsus Pharmaceuticals, Inc.