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

Primary Purpose

Meibomian Gland Dysfunction, Blepharitis, Demodex Infestation

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TP-03
TP-03 Vehicle
Sponsored by
Tarsus Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction focused on measuring Demodex

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mitchell C. Shultz, MDRecruiting
  • Silverstein Eye CenterRecruiting
  • Oculus ResearchRecruiting
  • Medical Optometry AmericaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

BID Dosing

TID Dosing

Arm Description

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

TP-03, lotilaner ophthalmic solution, 0.25% administered topically three times a day 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.

Secondary Outcome Measures

Full Information

First Posted
June 27, 2022
Last Updated
October 27, 2022
Sponsor
Tarsus Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05454956
Brief Title
Pilot Study Comparing the Safety and Efficacy of Two Dosing Regimens of TP-03 for the Treatment of MGD
Acronym
Ersa
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (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 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction, Blepharitis, Demodex Infestation
Keywords
Demodex

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Treatment assignment (BID or TID) will be unknown to the study participant, investigators and site staff performing study assessments.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BID Dosing
Arm Type
Experimental
Arm Description
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
Arm Title
TID Dosing
Arm Type
Experimental
Arm Description
TP-03, lotilaner ophthalmic solution, 0.25% administered topically three times a day for approximately 85 days
Intervention Type
Drug
Intervention Name(s)
TP-03
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
TP-03 Vehicle
Intervention Description
Vehicle of TP-03 ophthalmic solution, administered once a day in participants in the BID dosing arm to maintain masking between arms
Primary Outcome Measure Information:
Title
Treatment Emergent Adverse Events (TEAEs)
Description
TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term.
Time Frame
85 days
Other Pre-specified Outcome Measures:
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.
Time Frame
85 days
Title
Change from baseline in ocular surface staining assessed via slit lamp.
Description
Corneal fluorescein staining and conjunctival staining using lissamine green will be graded on a scale of 0 (normal) to 3 (severe)
Time Frame
85 days
Title
Change from baseline in dry eye symptoms using a visual analog scale, scores ranging from 0 to 100, evaluating eye dryness, ocular discomfort, fluctuating vision, burning, itching, and redness for the one week period prior to the in-office visit.
Time Frame
85 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dixie Kelly
Phone
714-460-7363
Ext
58
Email
ersa@promedica-intl.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Shultz, MD
Organizational Affiliation
Mitchell C. Shultz, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mitchell C. Shultz, MD
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
Silverstein Eye Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Lehning
Phone
816-358-3600
Email
jlehning@silversteineyecenters.com
Facility Name
Oculus Research
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27513
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristi Lang
Phone
919-391-7224
Email
kristi.lang@oculusresearch.com
Facility Name
Medical Optometry America
City
New Freedom
State/Province
Pennsylvania
ZIP/Postal Code
17349
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Bollinger
Phone
717-759-5929
Email
hbollinger@medodamerica.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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