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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BID Dosing | Experimental | 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 |
|
| TID Dosing | Experimental | TP-03, lotilaner ophthalmic solution, 0.25% administered topically three times a day for approximately 85 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TP-03 | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 85 days |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 85 visit |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell Shultz, MD | Mitchell C. Shultz, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mitchell C. Shultz, MD | Northridge | California | 91325 | United States | ||
| Silverstein Eye Center |
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The protocol stated up to 40 subjects to be enrolled. A total of 39 subjects were enrolled in the study which adhered to the protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | BID Dosing | TP-03, lotilaner ophthalmic solution, 0.25% administered topically twice a day and TP-03 vehicle administered once a day |
| FG001 | TID Dosing | TP-03, lotilaner ophthalmic solution, 0.25% administered topically three times a day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 1, 2023 | Dec 10, 2024 |
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Arm 1: Two doses of TP-03, 0.25% and one dose of TP-03 vehicle to maintain masking daily
Arm 2: Three doses of TP-03, 0.25% daily
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Treatment assignment (BID or TID) will be unknown to the study participant, investigators and site staff performing study assessments.
| TP-03 Vehicle | Drug | Vehicle of TP-03 ophthalmic solution, administered once a day in participants in the BID dosing arm to maintain masking between arms |
|
| 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). | Day 85 visit |
| Kansas City |
| Missouri |
| 64133 |
| United States |
| Oculus Research | Cary | North Carolina | 27513 | United States |
| CORE Inc. | Shelby | North Carolina | 28150 | United States |
| Medical Optometry America | New Freedom | Pennsylvania | 17349 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | BID Dosing | TP-03, lotilaner ophthalmic solution, 0.25% administered topically twice a day and TP-03 vehicle administered once a day |
| BG001 | TID Dosing | TP-03, lotilaner ophthalmic solution, 0.25% administered topically three times a day |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 85 days |
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| Other Pre-specified | 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 | The analysis eye is defined as the eye that meets all eligibility criteria and was randomized per protocol | Posted | Mean | Standard Deviation | score on a scale | Day 85 visit | analysis eye | analysis eye |
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| Other Pre-specified | 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). | The analysis eye is defined as the eye that meets all eligibility criteria and was randomized per protocol | Posted | Mean | Standard Deviation | score on a scale | Day 85 visit | analysis eye | analysis eye |
|
|
200 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BID Dosing | TP-03, lotilaner ophthalmic solution, 0.25% administered topically twice a day and TP-03 vehicle administered once a day | 0 | 21 | 1 | 21 | 8 | 21 |
| EG001 | TID Dosing | TP-03, lotilaner ophthalmic solution, 0.25% administered topically three times a day | 0 | 18 | 0 | 18 | 1 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Presyncope | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Ocular discomfort | Eye disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Conjunctivochalasis | Eye disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Chemical burns of eye | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hypercholesterolemia | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 25.0 | Non-systematic Assessment |
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It is specified in the protocol that the data generated in this clinical trial, all related information and any materials containing such data and information are the exclusive property of Tarsus Pharmaceuticals, Inc. and are confidential to Tarsus Pharmaceuticals. Also, the investigator or other study-related personnel may not disclose to anyone or use any data, information or materials related to this clinical trial without the express written consent of Tarsus Pharmaceuticals.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kavita Dhamdhere, Vice President of Clinical Development | Tarsus Pharmaceuticals, Inc. | 650-223-4062 | kdhamdhere@tarsusrx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 13, 2023 | Sep 11, 2025 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D000080343 | Meibomian Gland Dysfunction |
| D001762 | Blepharitis |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| analysis eye |
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| analysis eye |
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