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

Sponsor

Tarsus Pharmaceuticals, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04784091

Collaborator

(none)

418

Enrollment

Locations

Arms

8.1

Anticipated Duration (Months)

19.9

Patients Per Site

2.5

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, an eyedrop, to its vehicle control for the treatment of blepharitis due to Demodex, a microscopic mite frequently found in human hair follicles.

Condition or Disease	Intervention/Treatment	Phase
Blepharitis	Drug: TP-03 Drug: TP-03 Vehicle	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

418 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 3 Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis

Actual Study Start Date :

Apr 29, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Jan 1, 2022

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 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

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

Outcome Measures

Primary Outcome Measures

The proportion of participants cured based on their collarette score [43 days]

Secondary Outcome Measures

The proportion of participants with their Demodex mites eradicated [43 days]
The proportion of participants cured based on a composite of collarette score and erythema cure [43 days]

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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Global Retina Institute	Scottsdale	Arizona	United States	85254
2	Shultz Chang Vision	Northridge	California	United States	91325
3	East Bay Eye Center	San Ramon	California	United States	94583
4	Vision Institute	Colorado Springs	Colorado	United States	80907
5	Pinnacle Research Institute	Fort Lauderdale	Florida	United States	33309
6	Jackson Eye, S.C.	Lake Villa	Illinois	United States	60046
7	Michael Washburn Center for Ophthalmic Research LLC	Indianapolis	Indiana	United States	46113
8	Kannarr Eye Care	Pittsburg	Kansas	United States	66762
9	The Eye Care Institute	Louisville	Kentucky	United States	40206
10	Complete Eye Care of Medina	Medina	Minnesota	United States	55340
11	Tauber Eye Center	Kansas City	Missouri	United States	64111
12	Ophthalmology Associates	Saint Louis	Missouri	United States	63131
13	Matossian Eye Associates	Pennington	New Jersey	United States	08534
14	NC Eye Associates	Apex	North Carolina	United States	27502
15	Pure Ophthalmic Research	Mint Hill	North Carolina	United States	28227
16	Vita Eye Clinic	Shelby	North Carolina	United States	28150
17	Northern Ophthalmic Associates	Jenkintown	Pennsylvania	United States	19046
18	Alpine Research Organization / Healthy Heart Clinics of America	Clinton	Utah	United States	84015
19	Alpine Research Organization Inc./ Country Hills Eye Center	Ogden	Utah	United States	84403
20	Periman Eye Institute	Seattle	Washington	United States	98119
21	New River Vision Care	Oak Hill	West Virginia	United States	25901

Sponsors and Collaborators

Tarsus Pharmaceuticals, Inc.

Investigators

Principal Investigator: John Meyer, MD, The Eye Care Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tarsus Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT04784091

Other Study ID Numbers:

TRS-010

First Posted:

Mar 5, 2021

Last Update Posted:

Nov 5, 2021

Last Verified:

Nov 1, 2021

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

Study Results

No Results Posted as of Nov 5, 2021