Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis (Saturn-1)

Tarsus Pharmaceuticals

Status and phase: Completed; Phase 3; Phase 2

Conditions: Blepharitis

Treatments: Drug: TP-03 Vehicle; Drug: TP-03, 0.25%

Study type: Interventional

Funder types: Industry

Identifiers

NCT04475432

TRS-009

Details and patient eligibility

About

The purpose of this study is to compare the safety and efficacy of TP-03, 0.25%, an eyedrop, to its vehicle control for the treatment of blepharitis due to Demodex, a microscopic mite frequently found in human hair follicles. The hypothesis for the study is the proportion of participants cured at Day 43 with treatment by TP-03, 0.25%, is greater than the proportion cured by treatment with its vehicle.

Full description

This Phase 2b/3 study is a randomized, controlled, multicenter, double-masked, parallel trial to compare the safety and efficacy of TP-03, 0.25%, to vehicle control for the treatment of Demodex blepharitis. The primary objective of the study is to assess the safety and efficacy of TP-03 compared to its vehicle from Day 1 to Day 43 in adult participants with mild to severe Demodex blepharitis. The primary efficacy endpoint will be cure based upon collarettes. Safety will be determined by assessing adverse effects related to the treatment as well as evaluating any changes in visual acuity, intraocular pressure, slit lamp biomicroscopy and dilated ophthalmoscopy findings.

Enrollment: 421 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol
• Meet all of the following criteria in at least one eye: Have more than 10 lashes with collarettes present on the upper lid; have at least mild erythema of the upper eyelid margin; have an average Demodex density, upper and lower eyelids combined, of 1.5 or more mites per lash

Exclusion criteria

• Have used lid hygiene products within 14 days of Screening or unwilling to forego the use of lid hygiene products during the study
• Have worn contact lenses within 7 days of Screening or be unwilling to forego contact lens wear during the study
• Have used artificial eyelashes or eyelash extensions within 7 days of Screening or be unwilling to forego their use during the study
• Pregnancy or lactation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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421 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days

Treatment:

Drug: TP-03, 0.25%

Control

Placebo Comparator group

Description:

Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days

Treatment:

Drug: TP-03 Vehicle