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

Meibomian Gland Dysfunction Clinical Trial

— Ersa  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05454956
• Other study ID #: TRS-008
• Status: Completed
• Phase: Phase 2
• Start date: August 3, 2022
• Est. completion date: May 18, 2023

Study information

• Verified date: November 2023
• Source: Tarsus Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 18, 2023
• Est. primary completion date: May 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blepharitis
• Demodex Infestation
• Meibomian Gland Dysfunction
• Parasitic Diseases

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
• 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

Locations

Country	Name	City	State
United States	Oculus Research	Cary	North Carolina
United States	Silverstein Eye Center	Kansas City	Missouri
United States	Medical Optometry America	New Freedom	Pennsylvania
United States	Mitchell C. Shultz, MD	Northridge	California
United States	CORE Inc.	Shelby	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Tarsus Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in lower lid meibomian gland secretion score.	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).	85 days
Other	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
Other	Change from baseline in tear breakup time assessed via slit lamp.		85 days
Other	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
Other	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
Primary	Treatment Emergent Adverse Events (TEAEs)	TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term.	85 days