Clinical trial NCT04784091: Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis
Official title: Randomized, Controlled, Multicenter, Double-Masked, Parallel, Phase 3 Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Blepharitis
Keywords: Demodex
Lead sponsor: Tarsus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-05
Enrollment: 412
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, an eyedrop, to its vehicle control for the treatment of blepharitis due to Demodex, a microscopic mite frequently found in human hair follicles.

Detailed description: This Phase 3 study is a randomized, controlled, multicenter, double-masked, parallel trial to compare the safety and efficacy of TP-03 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, 0.25% 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, endothelial cell density, hematology, blood chemistry, and urinalysis.

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 used a prostaglandin analogue to promote eyelash growth within 30 days of Screening or any plans to initiate treatment 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
* Be pregnant or lactating at the time of Screening

Primary outcomes:
measure: The Proportion of Participants Cured Based on Their Collarette Score of 0 for the Upper Eyelid.
timeFrame: 43 days
Secondary outcomes:
measure: The Proportion of Participants With Their Demodex Mites Eradicated.
timeFrame: 43 days
measure: The Proportion of Participants Cured Based on a Composite of Collarette Score and Erythema Score
timeFrame: 43 days
measure: The Proportion of Participants Cured Based on Erythema Score.
timeFrame: 43 days
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Global Retina Institute
state: Arizona
city: Northridge
country: United States
facility: Shultz Chang Vision
state: California
city: San Ramon
country: United States
facility: East Bay Eye Center
state: California
city: Colorado Springs
country: United States
facility: Vision Institute
state: Colorado
city: Fort Lauderdale
country: United States
facility: Pinnacle Research Institute
state: Florida
city: Lake Villa
country: United States
facility: Jackson Eye, S.C.
state: Illinois
city: Columbus
country: United States
facility: Pankratz Eye Institute
state: Indiana
city: Indianapolis
country: United States
facility: Michael Washburn Center for Ophthalmic Research LLC
state: Indiana
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Louisville
country: United States
facility: The Eye Care Institute
state: Kentucky
city: Medina
country: United States
facility: Complete Eye Care of Medina
state: Minnesota
city: Kansas City
country: United States
facility: Tauber Eye Center
state: Missouri
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Apex
country: United States
facility: NC Eye Associates
state: North Carolina
city: Mint Hill
country: United States
facility: Pure Ophthalmic Research
state: North Carolina
city: Shelby
country: United States
facility: Vita Eye Clinic
state: North Carolina
city: Jenkintown
country: United States
facility: Northern Ophthalmic Associates
state: Pennsylvania
city: Clinton
country: United States
facility: Alpine Research Organization / Healthy Heart Clinics of America
state: Utah
city: Ogden
country: United States
facility: Alpine Research Organization Inc./ Country Hills Eye Center
state: Utah
city: Seattle
country: United States
facility: Periman Eye Institute
state: Washington
city: Oak Hill
country: United States
facility: New River Vision Care
state: West Virginia
Study officials:
affiliation: The Eye Care Institute
name: John Meyer, MD
role: PRINCIPAL_INVESTIGATOR
References: