Clinical trial NCT05454956: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meibomian Gland Dysfunction
Blepharitis
Demodex Infestation
Keywords: Demodex
Lead sponsor: Tarsus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Treatment Emergent Adverse Events (TEAEs)
timeFrame: 85 days
Secondary outcomes:
Other outcomes:
measure: Change from baseline in lower lid meibomian gland secretion score.
timeFrame: 85 days
measure: Change from baseline in lid margin erythema.
timeFrame: 85 days
measure: Change from baseline in tear breakup time assessed via slit lamp.
timeFrame: 85 days
measure: Change from baseline in ocular surface staining assessed via slit lamp.
timeFrame: 85 days
measure: 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.
timeFrame: 85 days
Locations:
city: Northridge
country: United States
facility: Mitchell C. Shultz, MD
state: California
city: Kansas City
country: United States
facility: Silverstein Eye Center
state: Missouri
city: Cary
country: United States
facility: Oculus Research
state: North Carolina
city: Shelby
country: United States
facility: CORE Inc.
state: North Carolina
city: New Freedom
country: United States
facility: Medical Optometry America
state: Pennsylvania
Study officials:
affiliation: Mitchell C. Shultz, MD
name: Mitchell Shultz, MD
role: PRINCIPAL_INVESTIGATOR
References: