Status:
ACTIVE_NOT_RECRUITING
Effect of an Exploratory Vehicle on Meibomian Gland Dysfunction in Patients With Demodex
Lead Sponsor:
Tarsus Pharmaceuticals, Inc.
Conditions:
Meibomian Gland Dysfunction
Demodex Infestation of Eyelid
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 Demo...
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 me...
Eligibility Criteria
Inclusion
- Key
- 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 with lash epilation of 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
- Key
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06054217
Start Date
August 1 2023
End Date
June 15 2024
Last Update
April 9 2024
Active Locations (2)
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1
Shultz Chang Vision
Northridge, California, United States, 91325
2
Vita Eye Clinic
Shelby, North Carolina, United States, 28150