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

NCT04784091 | Completed Phase 3 Results FDA Drug

• 1 other identifier: TRS-010
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 21

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.

Conditions

Blepharitis

Keywords

Demodex

Outcome Measures

Primary Outcomes (1)

• The Proportion of Participants Cured Based on Their Collarette Score of 0 for the Upper Eyelid.

  The proportion of subjects cured where cure is defined as 0-2 lashes with collarettes on the upper eyelid of the analysis eye. The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values

  43 days

Secondary Outcomes (3)

• The Proportion of Participants With Their Demodex Mites Eradicated.

  43 days

• The Proportion of Participants Cured Based on a Composite of Collarette Score and Erythema Score

  43 days

• The Proportion of Participants Cured Based on Erythema Score.

  43 days

Study Arms (2)

Active

EXPERIMENTAL

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

Drug: TP-03

Control

PLACEBO COMPARATOR

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

Drug: TP-03 Vehicle

Interventions

TP-03 DRUG

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

Active

TP-03 Vehicle DRUG

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tarsus Pharmaceuticals, Inc.: lead

Study Sites (21)

Global Retina Institute

Scottsdale, Arizona, 85254, United States

Location

Shultz Chang Vision

Northridge, California, 91325, United States

Location

East Bay Eye Center

San Ramon, California, 94583, United States

Location

Vision Institute

Colorado Springs, Colorado, 80907, United States

Location

Pinnacle Research Institute

Fort Lauderdale, Florida, 33309, United States

Location

Jackson Eye, S.C.

Lake Villa, Illinois, 60046, United States

Location

Pankratz Eye Institute

Columbus, Indiana, 47203, United States

Location

Michael Washburn Center for Ophthalmic Research LLC

Indianapolis, Indiana, 46113, United States

Location

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

The Eye Care Institute

Louisville, Kentucky, 40206, United States

Location

Complete Eye Care of Medina

Medina, Minnesota, 55340, United States

Location

Tauber Eye Center

Kansas City, Missouri, 64111, United States

Location

Ophthalmology Associates

St Louis, Missouri, 63131, United States

Location

NC Eye Associates

Apex, North Carolina, 27502, United States

Location

Pure Ophthalmic Research

Mint Hill, North Carolina, 28227, United States

Location

Vita Eye Clinic

Shelby, North Carolina, 28150, United States

Location

Northern Ophthalmic Associates

Jenkintown, Pennsylvania, 19046, United States

Location

Alpine Research Organization / Healthy Heart Clinics of America

Clinton, Utah, 84015, United States

Location

Alpine Research Organization Inc./ Country Hills Eye Center

Ogden, Utah, 84403, United States

Location

Periman Eye Institute

Seattle, Washington, 98119, United States

Location

New River Vision Care

Oak Hill, West Virginia, 25901, United States

Location

Related Publications (1)

• 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.

  PMID: 37285925 DERIVED

MeSH Terms

Conditions

Blepharitis

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Results Point of Contact

• Title: Mark Holdbrook, Senior Vice-President of Clinical Development
• Organization: Tarsus Pharmaceuticals

mark@tarsusrx.com

408-431-6613

Study Officials

• John Meyer, MD

  The Eye Care Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Treatment assignment will be unknown to the study participant, investigators and site staff performing study assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Active arm: TP-03, 0.25% Control arm: Vehicle of TP-03

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 5, 2021
• Study Start: April 29, 2021
• Primary Completion: May 9, 2022
• Study Completion: May 9, 2022
• Last Updated: December 21, 2023
• Results First Posted: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)