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

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

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.

Study Overview

• Status: Completed
• Conditions: Meibomian Gland Dysfunction; Blepharitis; Demodex Infestation
• Intervention / Treatment: Drug: TP-03; Drug: TP-03 Vehicle

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Northridge, California, United States, 91325
      • Mitchell C. Shultz, MD
  • Missouri
    • Kansas City, Missouri, United States, 64133
      • Silverstein Eye Center
  • North Carolina
    • Cary, North Carolina, United States, 27513
      • Oculus Research
    • Shelby, North Carolina, United States, 28150
      • Core Inc.
  • Pennsylvania
    • New Freedom, Pennsylvania, United States, 17349
      • Medical Optometry America

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BID Dosing; 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	Drug: TP-03; 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; Drug: TP-03 Vehicle; Vehicle of TP-03 ophthalmic solution, administered once a day in participants in the BID dosing arm to maintain masking between arms
Experimental: TID Dosing; TP-03, lotilaner ophthalmic solution, 0.25% administered topically three times a day for approximately 85 days	Drug: TP-03; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Emergent Adverse Events (TEAEs)	TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term.	85 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	85 days
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.	85 days
Change from baseline in tear breakup time assessed via slit lamp.		85 days
Change from baseline in ocular surface staining assessed via slit lamp.	Corneal fluorescein staining and conjunctival staining using lissamine green will be graded on a scale of 0 (normal) to 3 (severe)	85 days
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.		85 days

Collaborators and Investigators

• Sponsor: Tarsus Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Mitchell Shultz, MD, Mitchell C. Shultz, MD

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2022
• Primary Completion (Actual): May 18, 2023
• Study Completion (Actual): May 18, 2023

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Demodex
• Additional Relevant MeSH Terms: Infections; Eye Diseases; Eyelid Diseases; Meibomian Gland Dysfunction; Blepharitis; Parasitic Diseases
• Other Study ID Numbers: TRS-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No