Clinical trial NCT04475432: Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis
Official title: Randomized, Controlled, Multicenter, Double-Masked, Parallel, Phase 2b/3 Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Blepharitis
Keywords: Demodex
Lead sponsor: Tarsus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-17
Enrollment: 421
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Active arm: TP-03 0.25%

Control arm: Vehicle of TP-03
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Participants Cured Based on a Collarette Score at Day 43.
timeFrame: 43 days
Secondary outcomes:
measure: The Proportion of Participants With Eradication of Demodex Mites in the Analysis Eye at Day 43
timeFrame: 43 days
measure: Proportion of Participants Cured Based on a Composite Collarette and Erythema Score of 0 in the Analysis Eye at Day 43.
timeFrame: 43 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Cornea and Cataract Consultants of Arizona
state: Arizona
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Newport Beach
country: United States
facility: Visionary Eye Institute
state: California
city: Colorado Springs
country: United States
facility: Vision Institute
state: Colorado
city: Carmel
country: United States
facility: Midwest Cornea Associates, LLC
state: Indiana
city: Indianapolis
country: United States
facility: Washburn Research LLC
state: Indiana
city: Louisville
country: United States
facility: The Eye Care Institute
state: Kentucky
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Raleigh
country: United States
facility: Oculus Research, Inc at EyecareCenter
state: North Carolina
city: Shelby
country: United States
facility: Vita Eye Clinic
state: North Carolina
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates, PC
state: Pennsylvania
city: Memphis
country: United States
facility: Total Eye Care, P.A.
state: Tennessee
city: Layton
country: United States
facility: Alpine Research Organization
state: Utah
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
Study officials:
affiliation: Eye Research Foundation
name: David Wirta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yeu E, Wirta DL, Karpecki P, Baba SN, Holdbrook M; Saturn I Study Group. Lotilaner Ophthalmic Solution, 0.25%, for the Treatment of Demodex Blepharitis: Results of a Prospective, Randomized, Vehicle-Controlled, Double-Masked, Pivotal Trial (Saturn-1). Cornea. 2023 Apr 1;42(4):435-443. doi: 10.1097/ICO.0000000000003097. Epub 2022 Aug 10.