Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis (Saturn-2)

Randomized, Controlled, Multicenter, Double-Masked, Parallel, Phase 3 Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis

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.

Study Overview

• Status: Completed
• Conditions: Blepharitis
• Intervention / Treatment: Drug: TP-03; Drug: TP-03 Vehicle

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 Type: Interventional
• Enrollment (Actual): 412
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85254
      • Global Retina Institute
  • California
    • Northridge, California, United States, 91325
      • Shultz Chang Vision
    • San Ramon, California, United States, 94583
      • East Bay Eye Center
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Vision Institute
  • Florida
    • Fort Lauderdale, Florida, United States, 33309
      • Pinnacle Research Institute
  • Illinois
    • Lake Villa, Illinois, United States, 60046
      • Jackson Eye, S.C.
  • Indiana
    • Columbus, Indiana, United States, 47203
      • Pankratz Eye Institute
    • Indianapolis, Indiana, United States, 46113
      • Michael Washburn Center for Ophthalmic Research LLC
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Kannarr Eye Care
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • The Eye Care Institute
  • Minnesota
    • Medina, Minnesota, United States, 55340
      • Complete Eye Care of Medina
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Tauber Eye Center
    • Saint Louis, Missouri, United States, 63131
      • Ophthalmology Associates
  • North Carolina
    • Apex, North Carolina, United States, 27502
      • NC Eye Associates
    • Mint Hill, North Carolina, United States, 28227
      • Pure Ophthalmic Research
    • Shelby, North Carolina, United States, 28150
      • Vita Eye Clinic
  • Pennsylvania
    • Jenkintown, Pennsylvania, United States, 19046
      • Northern Ophthalmic Associates
  • Utah
    • Clinton, Utah, United States, 84015
      • Alpine Research Organization / Healthy Heart Clinics of America
    • Ogden, Utah, United States, 84403
      • Alpine Research Organization Inc./ Country Hills Eye Center
  • Washington
    • Seattle, Washington, United States, 98119
      • Periman Eye Institute
  • West Virginia
    • Oak Hill, West Virginia, United States, 25901
      • New River Vision Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active; TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days	Drug: TP-03; TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day
Placebo Comparator: Control; Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days	Drug: TP-03 Vehicle; Vehicle of TP-03 ophthalmic solution, administered twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Tarsus Pharmaceuticals, Inc.
• Investigators: Principal Investigator: John Meyer, MD, The Eye Care Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2021
• Primary Completion (Actual): May 9, 2022
• Study Completion (Actual): May 9, 2022

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 2, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Demodex
• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Blepharitis
• Other Study ID Numbers: TRS-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No