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

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ClinicalTrials.gov Identifier: NCT04475432
Recruitment Status : Completed
First Posted : July 17, 2020
Last Update Posted : July 7, 2021
Sponsor:
Information provided by (Responsible Party):
Tarsus Pharmaceuticals, Inc.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 421 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Active 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 : September 9, 2020
Actual Primary Completion Date : May 4, 2021
Actual Study Completion Date : May 4, 2021

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 Name: 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
Other Name: Inactive control




Primary Outcome Measures :
  1. The proportion of participants cured based on their collarette score [ Time Frame: 43 days ]
    Cure is defined as the presence of no more than 2 collarettes on the upper eyelid


Secondary Outcome Measures :
  1. The proportion of participants with their Demodex mites eradicated [ Time Frame: 43 days ]
    Mite eradication is defined as a mite density of 0 mites per lash

  2. The proportion of participants cured based on a composite of collarette score and erythema cure [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04475432


Locations
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United States, Arizona
Cornea and Cataract Consultants of Arizona
Phoenix, Arizona, United States, 85032
United States, California
Eye Research Foundation
Newport Beach, California, United States, 92663
Visionary Eye Institute
Newport Beach, California, United States, 92663
United States, Colorado
Vision Institute
Colorado Springs, Colorado, United States, 80907
United States, Indiana
Midwest Cornea Associates, LLC
Carmel, Indiana, United States, 46290
Washburn Research LLC
Indianapolis, Indiana, United States, 46240
United States, Kentucky
The Eye Care Institute
Louisville, Kentucky, United States, 40206
United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
United States, Missouri
Ophthalmology Associates
Saint Louis, Missouri, United States, 63131
United States, North Carolina
Oculus Research, Inc at EyecareCenter
Raleigh, North Carolina, United States, 27603
Vita Eye Clinic
Shelby, North Carolina, United States, 28150
United States, Pennsylvania
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, United States, 16066
United States, Tennessee
Total Eye Care, P.A.
Memphis, Tennessee, United States, 38119
United States, Utah
Alpine Research Organization
Layton, Utah, United States, 84041
United States, Virginia
Piedmont Eye Center
Lynchburg, Virginia, United States, 24502
Sponsors and Collaborators
Tarsus Pharmaceuticals, Inc.
Investigators
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Principal Investigator: David Wirta, MD Eye Research Foundation
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Responsible Party: Tarsus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04475432    
Other Study ID Numbers: TRS-009
First Posted: July 17, 2020    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tarsus Pharmaceuticals, Inc.:
Demodex
Additional relevant MeSH terms:
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Blepharitis
Eyelid Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions