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The purpose of this study is to compare the safety and efficacy of TP-03, an eyedrop, to its vehicle control for the treatment of blepharitis due to Demodex, a microscopic mite frequently found in human hair follicles.
This Phase 3 study is a randomized, controlled, multicenter, double-masked, parallel trial to compare the safety and efficacy of TP-03 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, 0.25% 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, endothelial cell density, hematology, blood chemistry, and urinalysis.
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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 | Drug | TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Participants Cured Based on Their Collarette Score of 0 for the Upper Eyelid. | The proportion of subjects 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 Their Demodex Mites Eradicated. | 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 |
|---|---|---|
| John Meyer, MD | The Eye Care Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Global Retina Institute | Scottsdale | Arizona | 85254 | United States | ||
| Shultz Chang Vision |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37285925 | Derived | Gaddie IB, Donnenfeld ED, Karpecki P, Vollmer P, Berdy GJ, Peterson JD, Simmons B, Edell ARP, Whitson WE, Ciolino JB, Baba SN, Holdbrook M, Trevejo J, Meyer J, Yeu E; Saturn-2 Study Group. Lotilaner Ophthalmic Solution 0.25% for Demodex Blepharitis: Randomized, Vehicle-Controlled, Multicenter, Phase 3 Trial (Saturn-2). Ophthalmology. 2023 Oct;130(10):1015-1023. doi: 10.1016/j.ophtha.2023.05.030. Epub 2023 Jun 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days TP-03: TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day |
| FG001 | Control |
| 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 | Dec 9, 2021 | Dec 2, 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 |
| The Proportion of Participants Cured Based on a Composite of Collarette Score and Erythema Score | 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 |
| The Proportion of Participants Cured Based on Erythema Score. | The proportion of participants cured based on erythema where cure is defined as having a normal eyelid erythema 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 |
| Northridge |
| California |
| 91325 |
| United States |
| East Bay Eye Center | San Ramon | California | 94583 | United States |
| Vision Institute | Colorado Springs | Colorado | 80907 | United States |
| Pinnacle Research Institute | Fort Lauderdale | Florida | 33309 | United States |
| Jackson Eye, S.C. | Lake Villa | Illinois | 60046 | United States |
| Pankratz Eye Institute | Columbus | Indiana | 47203 | United States |
| Michael Washburn Center for Ophthalmic Research LLC | Indianapolis | Indiana | 46113 | United States |
| Kannarr Eye Care | Pittsburg | Kansas | 66762 | United States |
| The Eye Care Institute | Louisville | Kentucky | 40206 | United States |
| Complete Eye Care of Medina | Medina | Minnesota | 55340 | United States |
| Tauber Eye Center | Kansas City | Missouri | 64111 | United States |
| Ophthalmology Associates | St Louis | Missouri | 63131 | United States |
| NC Eye Associates | Apex | North Carolina | 27502 | United States |
| Pure Ophthalmic Research | Mint Hill | North Carolina | 28227 | United States |
| Vita Eye Clinic | Shelby | North Carolina | 28150 | United States |
| Northern Ophthalmic Associates | Jenkintown | Pennsylvania | 19046 | United States |
| Alpine Research Organization / Healthy Heart Clinics of America | Clinton | Utah | 84015 | United States |
| Alpine Research Organization Inc./ Country Hills Eye Center | Ogden | Utah | 84403 | United States |
| Periman Eye Institute | Seattle | Washington | 98119 | United States |
| New River Vision Care | Oak Hill | West Virginia | 25901 | United States |
Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days
TP-03 Vehicle: Vehicle of TP-03 ophthalmic solution, administered twice a day
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days TP-03: TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day |
| BG001 | Control | Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days TP-03 Vehicle: Vehicle of TP-03 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | 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 | The Proportion of Participants Cured Based on Their Collarette Score of 0 for the Upper Eyelid. | The proportion of subjects 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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| Secondary | The Proportion of Participants With Their Demodex Mites Eradicated. | 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 |
|
| ||||||||||||||||||||||||||||||
| Secondary | The Proportion of Participants Cured Based on a Composite of Collarette Score and Erythema Score | 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 | Median | Standard Error | Proportion cured | 43 days |
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| ||||||||||||||||||||||||||||||
| Secondary | The Proportion of Participants Cured Based on Erythema Score. | The proportion of participants cured based on erythema where cure is defined as having a normal eyelid erythema 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 |
|
|
90 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 | Active | TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days | 0 | 203 | 4 | 203 | 49 | 203 |
| EG001 | Control | Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days | 0 | 209 | 3 | 209 | 28 | 209 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic retinopathy | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual acuity reduced | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Punctate keratitis | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Chalazion | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Conjunctival hyperaemia | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Instillation site pain | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | 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 | 408-431-6613 | mark@tarsusrx.com |
| Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 22, 2022 | Nov 28, 2023 | SAP_004.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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