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

Blepharitis Clinical Trial

— Saturn-1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04475432
• Other study ID #: TRS-009
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 9, 2020
• Est. completion date: May 4, 2021

Study information

• Verified date: December 2023
• Source: Tarsus Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 421
• Est. completion date: May 4, 2021
• Est. primary completion date: May 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blepharitis

Intervention

Drug:
• TP-03, 0.25%
TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day
• TP-03 Vehicle
Vehicle of TP-03 ophthalmic solution, administered twice a day

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts
United States	Midwest Cornea Associates, LLC	Carmel	Indiana
United States	Vision Institute	Colorado Springs	Colorado
United States	Scott & Christie and Associates, PC	Cranberry Township	Pennsylvania
United States	Washburn Research LLC	Indianapolis	Indiana
United States	Alpine Research Organization	Layton	Utah
United States	The Eye Care Institute	Louisville	Kentucky
United States	Piedmont Eye Center	Lynchburg	Virginia
United States	Total Eye Care, P.A.	Memphis	Tennessee
United States	Eye Research Foundation	Newport Beach	California
United States	Visionary Eye Institute	Newport Beach	California
United States	Cornea and Cataract Consultants of Arizona	Phoenix	Arizona
United States	Oculus Research, Inc at EyecareCenter	Raleigh	North Carolina
United States	Ophthalmology Associates	Saint Louis	Missouri
United States	Vita Eye Clinic	Shelby	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Tarsus Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Proportion of Participants With Eradication of Demodex Mites in the Analysis Eye at Day 43	The proportion of participants with Demodex mites eradicated at Day 43 where eradication is defined as a mite density of 0 mites/lash for the analysis eye. The mite density is obtained by epilating four of more lashes and dividing the number of mites observed under the microscope by the number of lashes.; 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	Proportion of Participants Cured Based on a Composite Collarette and Erythema Score of 0 in the Analysis Eye at Day 43.	The proportion of participants cured where cure is defined as a composite of the collarettes, 0-2 lashes with collarettes on the upper eyelid of the analysis eye, and normal lid margin erythema for the upper eyelid of the analysis eye at Day 43.; 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