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

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ClinicalTrials.gov Identifier: NCT05454956
Recruitment Status : Recruiting
First Posted : July 12, 2022
Last Update Posted : October 31, 2022
Sponsor:
Information provided by (Responsible Party):
Tarsus Pharmaceuticals, Inc.

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

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Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05454956


Contacts
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Contact: Dixie Kelly 714-460-7363 ext 58 ersa@promedica-intl.com

Locations
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United States, California
Mitchell C. Shultz, MD Recruiting
Northridge, California, United States, 91325
Contact: Karen Shultz    818-349-8300    karen.office.shultzchang@gmail.com   
United States, Missouri
Silverstein Eye Center Recruiting
Kansas City, Missouri, United States, 64133
Contact: Jessica Lehning    816-358-3600    jlehning@silversteineyecenters.com   
United States, North Carolina
Oculus Research Recruiting
Cary, North Carolina, United States, 27513
Contact: Kristi Lang    919-391-7224    kristi.lang@oculusresearch.com   
United States, Pennsylvania
Medical Optometry America Recruiting
New Freedom, Pennsylvania, United States, 17349
Contact: Heather Bollinger    717-759-5929    hbollinger@medodamerica.com   
Sponsors and Collaborators
Tarsus Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Mitchell Shultz, MD Mitchell C. Shultz, MD
More Information
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Responsible Party: Tarsus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT05454956    
Other Study ID Numbers: TRS-008
First Posted: July 12, 2022    Key Record Dates
Last Update Posted: October 31, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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