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

Primary Purpose

Blepharitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TP-03, 0.25%
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 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

Sites / Locations

  • Cornea and Cataract Consultants of Arizona
  • Eye Research Foundation
  • Visionary Eye Institute
  • Vision Institute
  • Midwest Cornea Associates, LLC
  • Washburn Research LLC
  • The Eye Care Institute
  • Andover Eye Associates
  • Ophthalmology Associates
  • Oculus Research, Inc at EyecareCenter
  • Vita Eye Clinic
  • Scott & Christie and Associates, PC
  • Total Eye Care, P.A.
  • Alpine Research Organization
  • Piedmont Eye Center

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
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
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
Cure is defined as the presence of no more than 2 collarettes and the absence of erythema (age normal) of the upper eyelid

Full Information

First Posted
July 14, 2020
Last Updated
July 7, 2022
Sponsor
Tarsus Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04475432
Brief Title
Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis
Acronym
Saturn-1
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
May 4, 2021 (Actual)
Study Completion Date
May 4, 2021 (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, 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.
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.

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 2, 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
421 (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, 0.25%
Other Intervention Name(s)
Lotilaner ophthalmic solution, 0.25%
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
Description
Cure is defined as the presence of no more than 2 collarettes on the upper eyelid
Time Frame
43 days
Secondary Outcome Measure Information:
Title
The proportion of participants with their Demodex mites eradicated
Description
Mite eradication is defined as a mite density of 0 mites per lash
Time Frame
43 days
Title
The proportion of participants cured based on a composite of collarette score and erythema cure
Description
Cure is defined as the presence of no more than 2 collarettes and the absence of erythema (age normal) of the upper eyelid
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Wirta, MD
Organizational Affiliation
Eye Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cornea and Cataract Consultants of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Visionary Eye Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Vision Institute
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Midwest Cornea Associates, LLC
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Washburn Research LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46240
Country
United States
Facility Name
The Eye Care Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
Ophthalmology Associates
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Oculus Research, Inc at EyecareCenter
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27603
Country
United States
Facility Name
Vita Eye Clinic
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Facility Name
Scott & Christie and Associates, PC
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Total Eye Care, P.A.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Alpine Research Organization
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Piedmont Eye Center
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35965392
Citation
Yeu E, Wirta DL, Karpecki P, Baba SN, Holdbrook M; Saturn I Study Group. Lotilaner Ophthalmic Solution, 0.25%, for the Treatment of Demodex Blepharitis: Results of a Prospective, Randomized, Vehicle-Controlled, Double-Masked, Pivotal Trial (Saturn-1). Cornea. 2023 Apr 1;42(4):435-443. doi: 10.1097/ICO.0000000000003097. Epub 2022 Aug 10.
Results Reference
derived

Learn more about this trial

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

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