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

NCT ID: NCT04475432

Last Updated: 2023-12-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

421 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-09

Study Completion Date

2021-05-04

Brief Summary

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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

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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.

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, 0.25%

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, 0.25%

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

Other Intervention Names

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Lotilaner ophthalmic solution, 0.25%

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 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
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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David Wirta, MD

Role: PRINCIPAL_INVESTIGATOR

Eye Research Foundation

Locations

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Cornea and Cataract Consultants of Arizona

Phoenix, Arizona, United States

Site Status

Eye Research Foundation

Newport Beach, California, United States

Site Status

Visionary Eye Institute

Newport Beach, California, United States

Site Status

Vision Institute

Colorado Springs, Colorado, United States

Site Status

Midwest Cornea Associates, LLC

Carmel, Indiana, United States

Site Status

Washburn Research LLC

Indianapolis, Indiana, United States

Site Status

The Eye Care Institute

Louisville, Kentucky, United States

Site Status

Andover Eye Associates

Andover, Massachusetts, United States

Site Status

Ophthalmology Associates

St Louis, Missouri, United States

Site Status

Oculus Research, Inc at EyecareCenter

Raleigh, North Carolina, United States

Site Status

Vita Eye Clinic

Shelby, North Carolina, United States

Site Status

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania, United States

Site Status

Total Eye Care, P.A.

Memphis, Tennessee, United States

Site Status

Alpine Research Organization

Layton, Utah, United States

Site Status

Piedmont Eye Center

Lynchburg, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35965392 (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-009

Identifier Type: -

Identifier Source: org_study_id