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

Sponsor

Tarsus Pharmaceuticals, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05454956

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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

Anticipated 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% dailyArm 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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 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

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

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

Other Outcome Measures

Change from baseline in lower lid meibomian gland secretion score. [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. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

No locations specified.

Sponsors and Collaborators

Tarsus Pharmaceuticals, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tarsus Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT05454956

Other Study ID Numbers:

TRS-008

First Posted:

Jul 12, 2022

Last Update Posted:

Jul 15, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Tarsus Pharmaceuticals, Inc.

Demodex

Additional relevant MeSH terms:

Parasitic Diseases

Meibomian Gland Dysfunction

Blepharitis

Study Results

No Results Posted as of Jul 15, 2022