Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis

Phase 3

Completed

• Conditions: Blepharitis
• Interventions: Drug: TP-03; Drug: TP-03 Vehicle

• Registration Number: NCT04784091
• Lead Sponsor: Tarsus Pharmaceuticals, Inc.

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-05
• Study Start: 2021-04-29
• Primary Completion: 2022-05-09
• Study Completion: 2022-05-09
• Disposition First Submitted: 2023-03-28
• Results First Submitted: 2023-08-25
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-02
• Last Update Submitted: 2023-12-02
• Results First Posted: 2023-12-21
• Disposition First Posted: 2023-12-21
• Last Update Posted: 2023-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 412

Inclusion Criteria

• Be willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol
• Meet all of the following criteria in at least one eye: Have more than 10 lashes with collarettes present on the upper lid; have at least mild erythema of the upper eyelid margin; have an average Demodex density, upper and lower eyelids combined, of 1.5 or more mites per lash

Exclusion Criteria

• Have used lid hygiene products within 14 days of Screening or unwilling to forego the use of lid hygiene products during the study
• Have used a prostaglandin analogue to promote eyelash growth within 30 days of Screening or any plans to initiate treatment during the study
• Have used artificial eyelashes or eyelash extensions within 7 days of Screening or be unwilling to forego their use during the study
• Be pregnant or lactating at the time of Screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	TP-03	TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days
Control	TP-03 Vehicle	Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days

Primary Outcome Measures

Name	Time	Method
The Proportion of Participants Cured Based on Their Collarette Score of 0 for the Upper Eyelid.	43 days	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

Secondary Outcome Measures

Name	Time	Method
The Proportion of Participants With Their Demodex Mites Eradicated.	43 days	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
The Proportion of Participants Cured Based on a Composite of Collarette Score and Erythema Score	43 days	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.
The Proportion of Participants Cured Based on Erythema Score.	43 days	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.

Trial Locations

Locations (21)

Shultz Chang Vision; 🇺🇸 Northridge, California, United States

Pankratz Eye Institute; 🇺🇸 Columbus, Indiana, United States

Periman Eye Institute; 🇺🇸 Seattle, Washington, United States

Jackson Eye, S.C.; 🇺🇸 Lake Villa, Illinois, United States

Global Retina Institute; 🇺🇸 Scottsdale, Arizona, United States

Vision Institute; 🇺🇸 Colorado Springs, Colorado, United States

Alpine Research Organization / Healthy Heart Clinics of America; 🇺🇸 Clinton, Utah, United States

Tauber Eye Center; 🇺🇸 Kansas City, Missouri, United States

Pure Ophthalmic Research; 🇺🇸 Mint Hill, North Carolina, United States

Alpine Research Organization Inc./ Country Hills Eye Center; 🇺🇸 Ogden, Utah, United States

East Bay Eye Center; 🇺🇸 San Ramon, California, United States

Pinnacle Research Institute; 🇺🇸 Fort Lauderdale, Florida, United States

Kannarr Eye Care; 🇺🇸 Pittsburg, Kansas, United States

Complete Eye Care of Medina; 🇺🇸 Medina, Minnesota, United States

The Eye Care Institute; 🇺🇸 Louisville, Kentucky, United States

NC Eye Associates; 🇺🇸 Apex, North Carolina, United States

Michael Washburn Center for Ophthalmic Research LLC; 🇺🇸 Indianapolis, Indiana, United States

Ophthalmology Associates; 🇺🇸 Saint Louis, Missouri, United States

Vita Eye Clinic; 🇺🇸 Shelby, North Carolina, United States

Northern Ophthalmic Associates; 🇺🇸 Jenkintown, Pennsylvania, United States

New River Vision Care; 🇺🇸 Oak Hill, West Virginia, United States