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

NCT ID: NCT04784091

Last Updated: 2023-12-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

412 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-29

Study Completion Date

2022-05-09

Brief Summary

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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

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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.

Conditions

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Blepharitis

Keywords

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Demodex

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Active arm: TP-03, 0.25% Control arm: Vehicle of TP-03
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Treatment assignment will be unknown to the study participant, investigators and site staff performing study assessments.

Study Groups

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Active

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

Group Type EXPERIMENTAL

TP-03

Intervention Type DRUG

TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day

Control

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

Group Type PLACEBO_COMPARATOR

TP-03 Vehicle

Intervention Type DRUG

Vehicle of TP-03 ophthalmic solution, administered twice a day

Interventions

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TP-03

TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day

Intervention Type DRUG

TP-03 Vehicle

Vehicle of TP-03 ophthalmic solution, administered twice a day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tarsus Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Meyer, MD

Role: PRINCIPAL_INVESTIGATOR

The Eye Care Institute

Locations

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Global Retina Institute

Scottsdale, Arizona, United States

Site Status

Shultz Chang Vision

Northridge, California, United States

Site Status

East Bay Eye Center

San Ramon, California, United States

Site Status

Vision Institute

Colorado Springs, Colorado, United States

Site Status

Pinnacle Research Institute

Fort Lauderdale, Florida, United States

Site Status

Jackson Eye, S.C.

Lake Villa, Illinois, United States

Site Status

Pankratz Eye Institute

Columbus, Indiana, United States

Site Status

Michael Washburn Center for Ophthalmic Research LLC

Indianapolis, Indiana, United States

Site Status

Kannarr Eye Care

Pittsburg, Kansas, United States

Site Status

The Eye Care Institute

Louisville, Kentucky, United States

Site Status

Complete Eye Care of Medina

Medina, Minnesota, United States

Site Status

Tauber Eye Center

Kansas City, Missouri, United States

Site Status

Ophthalmology Associates

St Louis, Missouri, United States

Site Status

NC Eye Associates

Apex, North Carolina, United States

Site Status

Pure Ophthalmic Research

Mint Hill, North Carolina, United States

Site Status

Vita Eye Clinic

Shelby, North Carolina, United States

Site Status

Northern Ophthalmic Associates

Jenkintown, Pennsylvania, United States

Site Status

Alpine Research Organization / Healthy Heart Clinics of America

Clinton, Utah, United States

Site Status

Alpine Research Organization Inc./ Country Hills Eye Center

Ogden, Utah, United States

Site Status

Periman Eye Institute

Seattle, Washington, United States

Site Status

New River Vision Care

Oak Hill, West Virginia, United States

Site Status

Countries

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United States

References

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Gaddie IB, Donnenfeld ED, Karpecki P, Vollmer P, Berdy GJ, Peterson JD, Simmons B, Edell ARP, Whitson WE, Ciolino JB, Baba SN, Holdbrook M, Trevejo J, Meyer J, Yeu E; Saturn-2 Study Group. Lotilaner Ophthalmic Solution 0.25% for Demodex Blepharitis: Randomized, Vehicle-Controlled, Multicenter, Phase 3 Trial (Saturn-2). Ophthalmology. 2023 Oct;130(10):1015-1023. doi: 10.1016/j.ophtha.2023.05.030. Epub 2023 Jun 5.

Reference Type DERIVED
PMID: 37285925 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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TRS-010

Identifier Type: -

Identifier Source: org_study_id