Pilot Study Comparing the Safety and Efficacy of Two Dosing Regimens of TP-03 for the Treatment of MGD

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, BID vs TID dosing regimens for the treatment of meibomian gland dysfunction in patients with Demodex lid infestation.

Detailed Description
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This Phase 2a study is a randomized, two-arm, double-masked, multicenter, parallel pilot study to compare the safety and efficacy of two dosing regimens of TP-03, BID vs TID, for the treatment of meibomian gland dysfunction in patients with Demodex lid infestation. The primary objective of the study is to assess the safety and efficacy of two dosing regimens of TP-03, 0.25% from Day 1 to Day 85 in adult participants with meibomian gland dysfunction in the presence of Demodex infestation. Efficacy will be determined by assessing lower lid meibomian gland secretion, lid margin erythema, bulbar redness, tear breakup time, ocular surface staining, and dry eye symptoms. Safety will be determined by assessing adverse effects related to the treatment as well as evaluating any changes in visual acuity and slit lamp biomicroscopy from baseline.

Official Title
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Randomized, Double-Masked, Pilot Study Comparing the Safety and Efficacy of Two Dosing Regimens of TP-03 for the Treatment of Meibomian Gland Dysfunction in Patients With Demodex Lid Infestation

Conditions
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Meibomian Gland Dysfunction, Blepharitis, Demodex Infestation

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 Meets all of the following criteria in at least one eye: have more than 10 lashes with collarettes present on the upper lid; have the presence of one or more mites in the upper and lower lids; have evidence of meibomian gland dysfunction; have at least mild erythema of the lower lid; have a tear breakup time of less than 10 seconds; and have intact partial to full meibomian glands in at least 33% of the total meibomian gland area of the lower lid Exclusion Criteria: Have used lid hygiene products within 7 days of Day 1 or unwilling to forego the use of lid hygiene products during the study Have used systemic antihistamines within 30 days of Day 1 Have used artificial eyelashes, eyelash extensions or had other cosmetic eyelash or eyelid procedures within 7 days of Day 1 or be unwilling to forego their use during the study Contact lens wear within 7 days of Day 1 or unwilling to forego contact lens wear for the duration of the study Be pregnant or lactating at Day 1

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: Arm 1: Two doses of TP-03, 0.25% and one dose of TP-03 vehicle to maintain masking daily Arm 2: Three doses of TP-03, 0.25% daily
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BID Dosing<br>TP-03, lotilaner ophthalmic solution, 0.25% administered topically twice a day and TP-03 vehicle administered once a day to maintain masking for approximately 85 days | Drug: TP-03<br>* TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day in participants in the BID dosing arm and three times a day in participants in the TID dosing arm<br>Drug: TP-03 Vehicle<br>* Vehicle of TP-03 ophthalmic solution, administered once a day in participants in the BID dosing arm to maintain masking between arms<br>|
| Experimental: TID Dosing<br>TP-03, lotilaner ophthalmic solution, 0.25% administered topically three times a day for approximately 85 days | Drug: TP-03<br>* TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day in participants in the BID dosing arm and three times a day in participants in the TID dosing arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Emergent Adverse Events (TEAEs) | TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term. | 85 days | 

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