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

• ClinicalTrials.gov Identifier: NCT04475432
• Recruitment Status: Completed
• First Posted: July 17, 2020
• Last Update Posted: July 7, 2021
• Sponsor: Tarsus Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Tarsus Pharmaceuticals, Inc.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Blepharitis	Drug: TP-03, 0.25%; Drug: TP-03 Vehicle	Phase 2; Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 421 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

Intervention Model Description

Active arm: TP-03 0.25%

Control arm: Vehicle of TP-03

• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Treatment assignment will be unknown to the study participant, investigators and site staff performing study assessments.
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: September 9, 2020
• Actual Primary Completion Date: May 4, 2021
• Actual Study Completion Date: May 4, 2021

Arms and Interventions

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 Name: 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; Other Name: Inactive control

Outcome Measures

Primary Outcome Measures :

1. The proportion of participants cured based on their collarette score [ Time Frame: 43 days ]
   Cure is defined as the presence of no more than 2 collarettes on the upper eyelid

Secondary Outcome Measures :

1. The proportion of participants with their Demodex mites eradicated [ Time Frame: 43 days ]
   Mite eradication is defined as a mite density of 0 mites per lash
2. The proportion of participants cured based on a composite of collarette score and erythema cure [ Time Frame: 43 days ]
   Cure is defined as the presence of no more than 2 collarettes and the absence of erythema (age normal) of the upper eyelid

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Arizona

Cornea and Cataract Consultants of Arizona

Phoenix, Arizona, United States, 85032

United States, California

Eye Research Foundation

Newport Beach, California, United States, 92663

Visionary Eye Institute

Newport Beach, California, United States, 92663

United States, Colorado

Vision Institute

Colorado Springs, Colorado, United States, 80907

United States, Indiana

Midwest Cornea Associates, LLC

Carmel, Indiana, United States, 46290

Washburn Research LLC

Indianapolis, Indiana, United States, 46240

United States, Kentucky

The Eye Care Institute

Louisville, Kentucky, United States, 40206

United States, Massachusetts

Andover Eye Associates

Andover, Massachusetts, United States, 01810

United States, Missouri

Ophthalmology Associates

Saint Louis, Missouri, United States, 63131

United States, North Carolina

Oculus Research, Inc at EyecareCenter

Raleigh, North Carolina, United States, 27603

Vita Eye Clinic

Shelby, North Carolina, United States, 28150

United States, Pennsylvania

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania, United States, 16066

United States, Tennessee

Total Eye Care, P.A.

Memphis, Tennessee, United States, 38119

United States, Utah

Alpine Research Organization

Layton, Utah, United States, 84041

United States, Virginia

Piedmont Eye Center

Lynchburg, Virginia, United States, 24502

Sponsors and Collaborators

Tarsus Pharmaceuticals, Inc.

Investigators

• Principal Investigator: David Wirta, MD; Eye Research Foundation

More Information

• Responsible Party: Tarsus Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT04475432
• Other Study ID Numbers: TRS-009
• First Posted: July 17, 2020
• Last Update Posted: July 7, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tarsus Pharmaceuticals, Inc.:

Demodex

Additional relevant MeSH terms:

Blepharitis; Eyelid Diseases; Eye Diseases; Ophthalmic Solutions; Pharmaceutical Solutions