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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-06-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05454956

Meibomian Gland Dysfunction Blepharitis Demodex Infestation

COMPLETED PHASE2

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

NCT04784091

Blepharitis

COMPLETED PHASE3

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

NCT04475432

Blepharitis

COMPLETED PHASE2/PHASE3

Impact of XDEMVY® on Demodex Blepharitis in Soft Contact Lens Wearers

NCT06182358

Demodex Blepharitis

COMPLETED PHASE4

An Evaluation of AZR-MD-001 as Treatment for Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD)

NCT03972501

Meibomian Gland Dysfunction (MGD) Contact Lens Discomfort (CLD)

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Meibomian Gland Dysfunction Demodex Infestation of Eyelid Blepharitis Demodectic Blepharitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study Cohort 1

Participants who were previously enrolled, dosed, and completed approximately 43 days of TID EV administration. Participants are crossed over to receive BID administration of EV for approximately 43 additional days.

Group Type EXPERIMENTAL

Vehicle of TP-03

Intervention Type DRUG

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

Study Cohort 2

Participants are randomized to receive BID administration of EV for approximately 85 days.

Group Type EXPERIMENTAL

Vehicle of TP-03

Intervention Type DRUG

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

Study Cohort 3

Participants are randomized to receive TID administration of EV for approximately 85 days

Group Type EXPERIMENTAL

Vehicle of TP-03

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vehicle of TP-03

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Exploratory Vehicle

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes