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The purpose of this study is to compare the safety and efficacy of TP-03, 0.25%, an eyedrop, to its vehicle control for the treatment of blepharitis due to Demodex, a microscopic mite frequently found in human hair follicles. The hypothesis for the study is the proportion of participants cured at Day 43 with treatment by TP-03, 0.25%, is greater than the proportion cured by treatment with its vehicle.
This Phase 2b/3 study is a randomized, controlled, multicenter, double-masked, parallel trial to compare the safety and efficacy of TP-03, 0.25%, to vehicle control for the treatment of Demodex blepharitis. The primary objective of the study is to assess the safety and efficacy of TP-03 compared to its vehicle from Day 1 to Day 43 in adult participants with mild to severe Demodex blepharitis. The primary efficacy endpoint will be cure based upon collarettes. Safety will be determined by assessing adverse effects related to the treatment as well as evaluating any changes in visual acuity, intraocular pressure, slit lamp biomicroscopy and dilated ophthalmoscopy findings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days |
|
| Control | Placebo Comparator | Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TP-03, 0.25% | Drug | TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Cured Based on a Collarette Score at Day 43. | The proportion of participants cured where cure is defined as 0-2 lashes with collarettes on the upper eyelid of the analysis eye. The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values. | 43 days |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Participants With Eradication of Demodex Mites in the Analysis Eye at Day 43 | The proportion of participants with Demodex mites eradicated at Day 43 where eradication is defined as a mite density of 0 mites/lash for the analysis eye. The mite density is obtained by epilating four of more lashes and dividing the number of mites observed under the microscope by the number of lashes. The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Wirta, MD | Eye Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cornea and Cataract Consultants of Arizona | Phoenix | Arizona | 85032 | United States | ||
| Eye Research Foundation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35965392 | Derived | Yeu E, Wirta DL, Karpecki P, Baba SN, Holdbrook M; Saturn I Study Group. Lotilaner Ophthalmic Solution, 0.25%, for the Treatment of Demodex Blepharitis: Results of a Prospective, Randomized, Vehicle-Controlled, Double-Masked, Pivotal Trial (Saturn-1). Cornea. 2023 Apr 1;42(4):435-443. doi: 10.1097/ICO.0000000000003097. Epub 2022 Aug 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day |
| FG001 | Control | Vehicle of TP-03 topical ophthalmic solution, administered twice 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 | Jan 25, 2021 | Nov 28, 2023 |
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Active arm: TP-03 0.25%
Control arm: Vehicle of TP-03
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Treatment assignment 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 twice a day |
|
| 43 days |
| Proportion of Participants Cured Based on a Composite Collarette and Erythema Score of 0 in the Analysis Eye at Day 43. | The proportion of participants cured where cure is defined as a composite of the collarettes, 0-2 lashes with collarettes on the upper eyelid of the analysis eye, and normal lid margin erythema for the upper eyelid of the analysis eye at Day 43. The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values. | 43 days |
| Newport Beach |
| California |
| 92663 |
| United States |
| Visionary Eye Institute | Newport Beach | California | 92663 | United States |
| Vision Institute | Colorado Springs | Colorado | 80907 | United States |
| Midwest Cornea Associates, LLC | Carmel | Indiana | 46290 | United States |
| Washburn Research LLC | Indianapolis | Indiana | 46240 | United States |
| The Eye Care Institute | Louisville | Kentucky | 40206 | United States |
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States |
| Ophthalmology Associates | St Louis | Missouri | 63131 | United States |
| Oculus Research, Inc at EyecareCenter | Raleigh | North Carolina | 27603 | United States |
| Vita Eye Clinic | Shelby | North Carolina | 28150 | United States |
| Scott & Christie and Associates, PC | Cranberry Township | Pennsylvania | 16066 | United States |
| Total Eye Care, P.A. | Memphis | Tennessee | 38119 | United States |
| Alpine Research Organization | Layton | Utah | 84041 | United States |
| Piedmont Eye Center | Lynchburg | Virginia | 24502 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day |
| BG001 | Control | Vehicle of TP-03 topical ophthalmic solution, administered twice 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Proportion of Participants Cured Based on a Collarette Score at Day 43. | The proportion of participants cured where cure is defined as 0-2 lashes with collarettes on the upper eyelid of the analysis eye. The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values. | Posted | Least Squares Mean | Standard Error | Proportion cured | 43 days |
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|
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| Secondary | The Proportion of Participants With Eradication of Demodex Mites in the Analysis Eye at Day 43 | The proportion of participants with Demodex mites eradicated at Day 43 where eradication is defined as a mite density of 0 mites/lash for the analysis eye. The mite density is obtained by epilating four of more lashes and dividing the number of mites observed under the microscope by the number of lashes. The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values | Posted | Least Squares Mean | Standard Error | Proportion eradicated | 43 days |
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| ||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants Cured Based on a Composite Collarette and Erythema Score of 0 in the Analysis Eye at Day 43. | The proportion of participants cured where cure is defined as a composite of the collarettes, 0-2 lashes with collarettes on the upper eyelid of the analysis eye, and normal lid margin erythema for the upper eyelid of the analysis eye at Day 43. The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values. | Posted | Least Squares Mean | Standard Error | Proportion cured | 43 days |
|
|
57 days
Corresponds to the standard definition.
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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 | Active | TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day for approximately 43 days | 0 | 212 | 3 | 212 | 37 | 212 |
| EG001 | Control | Vehicle of TP-03 topical ophthalmic solution, administered twice a day for approximately 43 days | 0 | 209 | 1 | 209 | 39 | 209 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Vascular access site pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual acuity reduced | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Chalazion | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Swelling of eyelid | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Instillation site pain | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Instillation site pruritus | General disorders | MedDRA 23.0 | 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 | |
|---|---|---|---|---|
| Mark Holdbrook, Senior Vice-President of Clinical Development | Tarsus Pharmaceuticals, Inc. | 408-431-6613 | mark@tarsusrx.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 26, 2021 | Dec 2, 2023 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D001762 | Blepharitis |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| >=65 years |
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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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