Trial to Evaluate the 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, an eyedrop, to its vehicle control for the treatment of blepharitis due to Demodex, a microscopic mite frequently found in human hair follicles.

Detailed Description
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This Phase 3 study is a randomized, controlled, multicenter, double-masked, parallel trial to compare the safety and efficacy of TP-03 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, 0.25% 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, endothelial cell density, hematology, blood chemistry, and urinalysis.

Official Title
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Randomized, Controlled, Multicenter, Double-Masked, Parallel, Phase 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
* 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 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

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<br>* TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day<br>|
| 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 |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Proportion of Participants With Their Demodex Mites Eradicated. | 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 | 
| The Proportion of Participants Cured Based on a Composite of Collarette Score and Erythema Score | 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 | 
| The Proportion of Participants Cured Based on Erythema Score. | The proportion of participants cured based on erythema where cure is defined as having a normal eyelid erythema 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