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

Primary Purpose

Blepharitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
TP-03
TP-03 Vehicle
Sponsored by
Tarsus Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blepharitis focused on measuring Demodex

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Global Retina Institute
  • Shultz Chang Vision
  • East Bay Eye Center
  • Vision Institute
  • Pinnacle Research Institute
  • Jackson Eye, S.C.
  • Pankratz Eye Institute
  • Michael Washburn Center for Ophthalmic Research LLC
  • Kannarr Eye Care
  • The Eye Care Institute
  • Complete Eye Care of Medina
  • Tauber Eye Center
  • Ophthalmology Associates
  • NC Eye Associates
  • Pure Ophthalmic Research
  • Vita Eye Clinic
  • Northern Ophthalmic Associates
  • Alpine Research Organization / Healthy Heart Clinics of America
  • Alpine Research Organization Inc./ Country Hills Eye Center
  • Periman Eye Institute
  • New River Vision Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Control

Arm Description

TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days

Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days

Outcomes

Primary Outcome Measures

The proportion of participants cured based on their collarette score

Secondary Outcome Measures

The proportion of participants with their Demodex mites eradicated
The proportion of participants cured based on a composite of collarette score and erythema score
The proportion of participants cured based on erythema score

Full Information

First Posted
March 2, 2021
Last Updated
April 1, 2023
Sponsor
Tarsus Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04784091
Brief Title
Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis
Acronym
Saturn-2
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 29, 2021 (Actual)
Primary Completion Date
May 9, 2022 (Actual)
Study Completion Date
May 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tarsus Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharitis
Keywords
Demodex

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Active arm: TP-03, 0.25% Control arm: Vehicle of TP-03
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Treatment assignment will be unknown to the study participant, investigators and site staff performing study assessments.
Allocation
Randomized
Enrollment
412 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days
Intervention Type
Drug
Intervention Name(s)
TP-03
Intervention Description
TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day
Intervention Type
Drug
Intervention Name(s)
TP-03 Vehicle
Intervention Description
Vehicle of TP-03 ophthalmic solution, administered twice a day
Primary Outcome Measure Information:
Title
The proportion of participants cured based on their collarette score
Time Frame
43 days
Secondary Outcome Measure Information:
Title
The proportion of participants with their Demodex mites eradicated
Time Frame
43 days
Title
The proportion of participants cured based on a composite of collarette score and erythema score
Time Frame
43 days
Title
The proportion of participants cured based on erythema score
Time Frame
43 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Meyer, MD
Organizational Affiliation
The Eye Care Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Global Retina Institute
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Facility Name
Shultz Chang Vision
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
East Bay Eye Center
City
San Ramon
State/Province
California
ZIP/Postal Code
94583
Country
United States
Facility Name
Vision Institute
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Pinnacle Research Institute
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Facility Name
Jackson Eye, S.C.
City
Lake Villa
State/Province
Illinois
ZIP/Postal Code
60046
Country
United States
Facility Name
Pankratz Eye Institute
City
Columbus
State/Province
Indiana
ZIP/Postal Code
47203
Country
United States
Facility Name
Michael Washburn Center for Ophthalmic Research LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46113
Country
United States
Facility Name
Kannarr Eye Care
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
The Eye Care Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Complete Eye Care of Medina
City
Medina
State/Province
Minnesota
ZIP/Postal Code
55340
Country
United States
Facility Name
Tauber Eye Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Ophthalmology Associates
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
NC Eye Associates
City
Apex
State/Province
North Carolina
ZIP/Postal Code
27502
Country
United States
Facility Name
Pure Ophthalmic Research
City
Mint Hill
State/Province
North Carolina
ZIP/Postal Code
28227
Country
United States
Facility Name
Vita Eye Clinic
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Facility Name
Northern Ophthalmic Associates
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Alpine Research Organization / Healthy Heart Clinics of America
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
Alpine Research Organization Inc./ Country Hills Eye Center
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Periman Eye Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98119
Country
United States
Facility Name
New River Vision Care
City
Oak Hill
State/Province
West Virginia
ZIP/Postal Code
25901
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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