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

Sponsor

Tarsus Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04475432

Collaborator

(none)

421

Enrollment

Locations

Arms

7.8

Actual Duration (Months)

28.1

Patients Per Site

3.6

Patients Per Site Per Month

Study Details

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

Actual Enrollment :

421 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Active arm: TP-03 0.25% Control arm: Vehicle of TP-03Active 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 :

Sep 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 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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

The proportion of participants with their Demodex mites eradicated [43 days]
Mite eradication is defined as a mite density of 0 mites per lash
The proportion of participants cured based on a composite of collarette score and erythema cure [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	Cornea and Cataract Consultants of Arizona	Phoenix	Arizona	United States	85032
2	Eye Research Foundation	Newport Beach	California	United States	92663
3	Visionary Eye Institute	Newport Beach	California	United States	92663
4	Vision Institute	Colorado Springs	Colorado	United States	80907
5	Midwest Cornea Associates, LLC	Carmel	Indiana	United States	46290
6	Washburn Research LLC	Indianapolis	Indiana	United States	46240
7	The Eye Care Institute	Louisville	Kentucky	United States	40206
8	Andover Eye Associates	Andover	Massachusetts	United States	01810
9	Ophthalmology Associates	Saint Louis	Missouri	United States	63131
10	Oculus Research, Inc at EyecareCenter	Raleigh	North Carolina	United States	27603
11	Vita Eye Clinic	Shelby	North Carolina	United States	28150
12	Scott & Christie and Associates, PC	Cranberry Township	Pennsylvania	United States	16066
13	Total Eye Care, P.A.	Memphis	Tennessee	United States	38119
14	Alpine Research Organization	Layton	Utah	United States	84041
15	Piedmont Eye Center	Lynchburg	Virginia	United States	24502

Sponsors and Collaborators

Tarsus Pharmaceuticals, Inc.

Investigators

Principal Investigator: David Wirta, MD, Eye Research Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tarsus Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT04475432

Other Study ID Numbers:

TRS-009

First Posted:

Jul 17, 2020

Last Update Posted:

Jul 11, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Tarsus Pharmaceuticals, Inc.

Demodex

Additional relevant MeSH terms:

Blepharitis

Ophthalmic Solutions

Study Results

No Results Posted as of Jul 11, 2022