Back to resultsEffect of an Exploratory Vehicle on Meibomian Gland Dysfunction in Patients With Demodex (Rhea)
Primary Purpose
Meibomian Gland Dysfunction, Demodex Infestation of Eyelid, Blepharitis
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vehicle of TP-03
Sponsored by
About this trial
This is an interventional treatment trial for Meibomian Gland Dysfunction focused on measuring Demodex
Eligibility Criteria
Key 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 Key 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
Sites / Locations
- Shultz Chang VisionRecruiting
- Vita Eye ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Study Cohort 1
Study Cohort 2
Study Cohort 3
Arm Description
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.
Participants are randomized to receive BID administration of EV for approximately 85 days.
Participants are randomized to receive TID administration of EV for approximately 85 days
Outcomes
Primary Outcome Measures
Treatment Emergent Adverse Events (TEAEs)
TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term.
TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term.
Secondary Outcome Measures
Change from baseline in lower lid meibomian gland secretion score
For each of the 15 glands expressed, secretion characteristics will be graded via slit lamp examination on a scale of 0 to 3 (3=clear liquid secretion; 2=cloudy liquid secretion; 1=granularly opaque liquid secretion to inspissated/toothpaste consistency; and 0=no secretion).
Change from baseline in lid margin erythema.
Erythema of the eyelid margin will be assessed via slit lamp examination and graded on a scale of 0 (normal) to 3 (severe) for the upper and lower eyelids of each eye.
Change from baseline in tear breakup time assessed via slit lamp
Tear breakup time will be assessed via slit lamp examination and timed in seconds to two significant digits.
Full Information
NCT ID
NCT06054217
First Posted
September 19, 2023
Last Updated
September 28, 2023
Sponsor
Tarsus Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT06054217
Brief Title
Effect of an Exploratory Vehicle on Meibomian Gland Dysfunction in Patients With Demodex
Acronym
Rhea
Official Title
Evaluating the Effect of Two Dosing Regimens of an Exploratory Vehicle on Meibomian Gland Dysfunction in Patients With Demodex Lid Infestation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
January 15, 2024 (Anticipated)
Study Completion Date
January 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tarsus Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction, Demodex Infestation of Eyelid, Blepharitis, Demodectic Blepharitis
Keywords
Demodex
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study Cohort 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Study Cohort 2
Arm Type
Experimental
Arm Description
Participants are randomized to receive BID administration of EV for approximately 85 days.
Arm Title
Study Cohort 3
Arm Type
Experimental
Arm Description
Participants are randomized to receive TID administration of EV for approximately 85 days
Intervention Type
Drug
Intervention Name(s)
Vehicle of TP-03
Other Intervention Name(s)
Exploratory Vehicle
Intervention Description
The Exploratory Vehicle is the vehicle of TP-03 (lotilaner ophthalmic solution, 0.25%)
Primary Outcome Measure Information:
Title
Treatment Emergent Adverse Events (TEAEs)
Description
TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term.
TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term.
Time Frame
85 days
Secondary Outcome Measure Information:
Title
Change from baseline in lower lid meibomian gland secretion score
Description
For each of the 15 glands expressed, secretion characteristics will be graded via slit lamp examination on a scale of 0 to 3 (3=clear liquid secretion; 2=cloudy liquid secretion; 1=granularly opaque liquid secretion to inspissated/toothpaste consistency; and 0=no secretion).
Time Frame
85 days
Title
Change from baseline in lid margin erythema.
Description
Erythema of the eyelid margin will be assessed via slit lamp examination and graded on a scale of 0 (normal) to 3 (severe) for the upper and lower eyelids of each eye.
Time Frame
85 days
Title
Change from baseline in tear breakup time assessed via slit lamp
Description
Tear breakup time will be assessed via slit lamp examination and timed in seconds to two significant digits.
Time Frame
85 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key 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
Key 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Anderson
Phone
480-299-3918
Email
janderson@tarsusrx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell C Shultz, MD
Organizational Affiliation
Shultz Chang Vision
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shultz Chang Vision
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Shultz
Phone
818-349-8300
Email
karen.office.shultzchang@gmail.com
Facility Name
Vita Eye Clinic
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Winnie Simmons
Phone
501-322-0505
Email
winniesimmons.core@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of an Exploratory Vehicle on Meibomian Gland Dysfunction in Patients With Demodex
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