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.

Tracking Information

• First Submitted Date: June 27, 2022
• First Posted Date: July 12, 2022
• Last Update Posted Date: November 13, 2023
• Actual Study Start Date: August 3, 2022
• Actual Primary Completion Date: May 18, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 13, 2022)

Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 85 days ]

TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term.

Original Primary Outcome Measures (submitted: July 7, 2022)

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).

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided

Current Other Pre-specified Outcome Measures (submitted: October 27, 2022)

• 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).
• 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.
• Change from baseline in tear breakup time assessed via slit lamp. [ Time Frame: 85 days ]
• 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)
• 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 ]

Original Other Pre-specified Outcome Measures (submitted: July 7, 2022)

• 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. [ Time Frame: 85 days ]
• Change from baseline in tear breakup time assessed via slit lamp. [ Time Frame: 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) [ Time Frame: 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. [ Time Frame: 85 days ]

Descriptive Information

• Brief Title: Pilot Study Comparing the Safety and Efficacy of Two Dosing Regimens of TP-03 for the Treatment of MGD
• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 2

Study Design

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

Condition

• Meibomian Gland Dysfunction
• Blepharitis
• Demodex Infestation

Intervention

• 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

Study Arms

• 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
  Interventions:

  • Drug: TP-03
  • Drug: TP-03 Vehicle
• Experimental: TID Dosing
  TP-03, lotilaner ophthalmic solution, 0.25% administered topically three times a day for approximately 85 days
  Intervention: Drug: TP-03

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 7, 2022): 40
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 18, 2023
• Actual Primary Completion Date: May 18, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05454956
• Other Study ID Numbers: TRS-008
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Tarsus Pharmaceuticals, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Tarsus Pharmaceuticals, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Tarsus Pharmaceuticals, Inc.
• Verification Date: November 2023