NCT06054217

Effect of an Exploratory Vehicle on Meibomian Gland Dysfunction in Patients With Demodex

Evaluating the Effect of Two Dosing Regimens of an Exploratory Vehicle on Meibomian Gland Dysfunction in Patients With Demodex Lid Infestation

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Tarsus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate and compare the effect of two dosing regimens, BID versus TID dosing, of an Exploratory Vehicle (EV) on meibomian gland dysfunction (MGD) in patients with Demodex lid infestation.

Detailed description

This is a prospective, randomized controlled, three-arm, investigator- and interpreter-masked study. This study is intended to compare the effect of two dosing regimens of an exploratory vehicle on meibomian gland dysfunction (MGD) in participants with Demodex lid infestation. Approximately 12 participants will be enrolled in each arm. The administration period will last for approximately 85 days.

Conditions

• Meibomian Gland Dysfunction
• Demodex Infestation of Eyelid
• Blepharitis
• Demodectic Blepharitis

Interventions

Type	Name	Description
DRUG	Vehicle of TP-03	The Exploratory Vehicle is the vehicle of TP-03 (lotilaner ophthalmic solution, 0.25%)

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-06-15
• Completion: 2024-06-15
• First posted: 2023-09-26
• Last updated: 2024-04-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study