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

NCT04475432 | Completed Phase 2 Results FDA Drug

• 1 other identifier: TRS-009
• Study Type: interventional
• Target: 421
• Locations: 1 country
• Sites: 15

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.

Conditions

Blepharitis

Keywords

Demodex

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Cured Based on a Collarette Score at Day 43.

  The proportion of participants 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 (2)

• The Proportion of Participants With Eradication of Demodex Mites in the Analysis Eye at Day 43

  43 days

• Proportion of Participants Cured Based on a Composite Collarette and Erythema Score of 0 in the Analysis Eye at Day 43.

  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, 0.25%

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, 0.25% DRUG

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

Also known as: Lotilaner ophthalmic solution, 0.25%

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 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

Sponsors & Collaborators

• Tarsus Pharmaceuticals, Inc.: lead

Study Sites (15)

Cornea and Cataract Consultants of Arizona

Phoenix, Arizona, 85032, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Visionary Eye Institute

Newport Beach, California, 92663, United States

Location

Vision Institute

Colorado Springs, Colorado, 80907, United States

Location

Midwest Cornea Associates, LLC

Carmel, Indiana, 46290, United States

Location

Washburn Research LLC

Indianapolis, Indiana, 46240, United States

Location

The Eye Care Institute

Louisville, Kentucky, 40206, United States

Location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

Ophthalmology Associates

St Louis, Missouri, 63131, United States

Location

Oculus Research, Inc at EyecareCenter

Raleigh, North Carolina, 27603, United States

Location

Vita Eye Clinic

Shelby, North Carolina, 28150, United States

Location

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania, 16066, United States

Location

Total Eye Care, P.A.

Memphis, Tennessee, 38119, United States

Location

Alpine Research Organization

Layton, Utah, 84041, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 24502, United States

Location

Related Publications (1)

• 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.

  PMID: 35965392 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, Inc.

mark@tarsusrx.com

408-431-6613

Study Officials

• David Wirta, MD

  Eye Research Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: July 14, 2020
• First Posted: July 17, 2020
• Study Start: September 9, 2020
• Primary Completion: May 4, 2021
• Study Completion: May 4, 2021
• 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 (15)