Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis (Saturn-1)

Randomized, Controlled, Multicenter, Double-Masked, Parallel, Phase 2b/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, 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.

Study Overview

• Status: Completed
• Conditions: Blepharitis
• Intervention / Treatment: Drug: TP-03 Vehicle; Drug: TP-03, 0.25%

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 421
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Cornea and Cataract Consultants of Arizona
  • California
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
    • Newport Beach, California, United States, 92663
      • Visionary Eye Institute
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Vision Institute
  • Indiana
    • Carmel, Indiana, United States, 46290
      • Midwest Cornea Associates, LLC
    • Indianapolis, Indiana, United States, 46240
      • Washburn Research LLC
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • The Eye Care Institute
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates
  • Missouri
    • Saint Louis, Missouri, United States, 63131
      • Ophthalmology Associates
  • North Carolina
    • Raleigh, North Carolina, United States, 27603
      • Oculus Research, Inc at EyecareCenter
    • Shelby, North Carolina, United States, 28150
      • Vita Eye Clinic
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Scott & Christie and Associates, PC
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care, P.A.
  • Utah
    • Layton, Utah, United States, 84041
      • Alpine Research Organization
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Piedmont Eye Center

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 worn contact lenses within 7 days of Screening or be unwilling to forego contact lens wear 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
• Pregnancy or lactation

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, 0.25%; TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day; Other Names: Lotilaner ophthalmic solution, 0.25%
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
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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Tarsus Pharmaceuticals, Inc.
• Investigators: Principal Investigator: David Wirta, MD, Eye Research Foundation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2020
• Primary Completion (Actual): May 4, 2021
• Study Completion (Actual): May 4, 2021

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 16, 2020
• First Posted (Actual): July 17, 2020

Study Record Updates

• Last Update Posted (Actual): 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; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: TRS-009

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