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

Phase 2

Completed

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.

Detailed 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 & 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

Arm && Interventions

Group	Intervention	Description
Active	TP-03, 0.25%	TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days
Control	TP-03 Vehicle	Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days

Primary Outcome Measures

Name	Time	Method
Proportion of Participants Cured Based on a Collarette Score at Day 43.	43 days	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.

Secondary Outcome Measures

Name	Time	Method
The Proportion of Participants With Eradication of Demodex Mites in the Analysis Eye at Day 43	43 days	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
Proportion of Participants Cured Based on a Composite Collarette and Erythema Score of 0 in the Analysis Eye at Day 43.	43 days	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.

Locations (15): Vision Institute
🇺🇸
Colorado Springs, Colorado, United States
Alpine Research Organization
🇺🇸
Layton, Utah, United States
Cornea and Cataract Consultants of Arizona
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Phoenix, Arizona, United States
Eye Research Foundation
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Newport Beach, California, United States
Visionary Eye Institute
🇺🇸
Newport Beach, California, United States
Midwest Cornea Associates, LLC
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Carmel, Indiana, United States
Washburn Research LLC
🇺🇸
Indianapolis, Indiana, United States
The Eye Care Institute
🇺🇸
Louisville, Kentucky, United States
Oculus Research, Inc at EyecareCenter
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Raleigh, North Carolina, United States
Vita Eye Clinic
🇺🇸
Shelby, North Carolina, United States
Ophthalmology Associates
🇺🇸
Saint Louis, Missouri, United States
Scott & Christie and Associates, PC
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Cranberry Township, Pennsylvania, United States
Total Eye Care, P.A.
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Memphis, Tennessee, United States
Piedmont Eye Center
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Lynchburg, Virginia, United States
Andover Eye Associates
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Andover, Massachusetts, United States