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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 : Completed
First Posted : July 12, 2022
Last Update Posted : November 13, 2023
Sponsor:
Information provided by (Responsible Party):
Tarsus Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE June 27, 2022
First Posted Date  ICMJE July 12, 2022
Last Update Posted Date November 13, 2023
Actual Study Start Date  ICMJE August 3, 2022
Actual Primary Completion Date May 18, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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).
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE 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  ICMJE Pilot Study Comparing the Safety and Efficacy of Two Dosing Regimens of TP-03 for the Treatment of MGD
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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  ICMJE
  • Meibomian Gland Dysfunction
  • Blepharitis
  • Demodex Infestation
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2022)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 18, 2023
Actual Primary Completion Date May 18, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05454956
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Current Responsible Party Tarsus Pharmaceuticals, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Tarsus Pharmaceuticals, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mitchell Shultz, MD Mitchell C. Shultz, MD
PRS Account Tarsus Pharmaceuticals, Inc.
Verification Date November 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP