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
21
Locations
2
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 DiseaseIntervention/TreatmentPhase
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

ArmIntervention/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

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

Secondary Outcome Measures

  1. The proportion of participants with their Demodex mites eradicated [43 days]

  2. 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:
No
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

SiteCityStateCountryPostal Code
1Global Retina InstituteScottsdaleArizonaUnited States85254
2Shultz Chang VisionNorthridgeCaliforniaUnited States91325
3East Bay Eye CenterSan RamonCaliforniaUnited States94583
4Vision InstituteColorado SpringsColoradoUnited States80907
5Pinnacle Research InstituteFort LauderdaleFloridaUnited States33309
6Jackson Eye, S.C.Lake VillaIllinoisUnited States60046
7Michael Washburn Center for Ophthalmic Research LLCIndianapolisIndianaUnited States46113
8Kannarr Eye CarePittsburgKansasUnited States66762
9The Eye Care InstituteLouisvilleKentuckyUnited States40206
10Complete Eye Care of MedinaMedinaMinnesotaUnited States55340
11Tauber Eye CenterKansas CityMissouriUnited States64111
12Ophthalmology AssociatesSaint LouisMissouriUnited States63131
13Matossian Eye AssociatesPenningtonNew JerseyUnited States08534
14NC Eye AssociatesApexNorth CarolinaUnited States27502
15Pure Ophthalmic ResearchMint HillNorth CarolinaUnited States28227
16Vita Eye ClinicShelbyNorth CarolinaUnited States28150
17Northern Ophthalmic AssociatesJenkintownPennsylvaniaUnited States19046
18Alpine Research Organization / Healthy Heart Clinics of AmericaClintonUtahUnited States84015
19Alpine Research Organization Inc./ Country Hills Eye CenterOgdenUtahUnited States84403
20Periman Eye InstituteSeattleWashingtonUnited States98119
21New River Vision CareOak HillWest VirginiaUnited States25901

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:
No
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.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 5, 2021