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

• ClinicalTrials.gov Identifier: NCT05454956
• Recruitment Status: Completed
• First Posted: July 12, 2022
• Last Update Posted: November 13, 2023
• Sponsor: Tarsus Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Tarsus Pharmaceuticals, Inc.

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.

Condition or disease	Intervention/treatment	Phase
Meibomian Gland Dysfunction; Blepharitis; Demodex Infestation	Drug: TP-03; Drug: TP-03 Vehicle	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Treatment assignment (BID or TID) will be unknown to the study participant, investigators and site staff performing study assessments.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: August 3, 2022
• Actual Primary Completion Date: May 18, 2023
• Actual Study Completion Date: May 18, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 85 days ]
   TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term.

Other Outcome Measures:

1. Change from baseline in lower lid meibomian gland secretion score. [ Time Frame: 85 days ]
   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).
2. Change from baseline in lid margin erythema. [ Time Frame: 85 days ]
   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.
3. Change from baseline in tear breakup time assessed via slit lamp. [ Time Frame: 85 days ]
4. Change from baseline in ocular surface staining assessed via slit lamp. [ Time Frame: 85 days ]
   Corneal fluorescein staining and conjunctival staining using lissamine green will be graded on a scale of 0 (normal) to 3 (severe)
5. 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 ]

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, California

Mitchell C. Shultz, MD

Northridge, California, United States, 91325

United States, Missouri

Silverstein Eye Center

Kansas City, Missouri, United States, 64133

United States, North Carolina

Oculus Research

Cary, North Carolina, United States, 27513

CORE Inc.

Shelby, North Carolina, United States, 28150

United States, Pennsylvania

Medical Optometry America

New Freedom, Pennsylvania, United States, 17349

Sponsors and Collaborators

Tarsus Pharmaceuticals, Inc.

Investigators

• Principal Investigator: Mitchell Shultz, MD; Mitchell C. Shultz, MD

More Information

• Responsible Party: Tarsus Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT05454956
• Other Study ID Numbers: TRS-008
• First Posted: July 12, 2022
• Last Update Posted: November 13, 2023
• Last Verified: November 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tarsus Pharmaceuticals, Inc.:

Demodex

Additional relevant MeSH terms:

Parasitic Diseases; Meibomian Gland Dysfunction; Blepharitis; Eyelid Diseases; Eye Diseases; Infections