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

Study Overview
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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.

Official Title
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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

Conditions
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Blepharitis

Intervention / Treatment
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* Drug: TP-03, 0.25%
* Drug: TP-03 Vehicle


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Active arm: TP-03 0.25% Control arm: Vehicle of TP-03
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days | Drug: TP-03, 0.25%<br>* TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day<br>* Other names: Lotilaner ophthalmic solution, 0.25%;|
| Placebo Comparator: Control<br>Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days | Drug: TP-03 Vehicle<br>* Vehicle of TP-03 ophthalmic solution, administered twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Demodex