Phase 3 N=421 Randomized Quadruple-blind Treatment

Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis

Blepharitis

Bottom Line

View on ClinicalTrials.gov: NCT04475432 ↗

Enrolled (actual)

421

Serious AEs

1.0%

Results posted

Dec 2023

Primary outcome: Primary: Proportion of Participants Cured Based on a Collarette Score at Day 43. — 0.439; 0.072 Proportion cured

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: TP-03, 0.25% (Drug); TP-03 Vehicle (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Tarsus Pharmaceuticals, Inc.
Primary completion: May 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Participants Cured Based on a Collarette Score at Day 43.	0.439; 0.072	—
SECONDARY The Proportion of Participants With Eradication of Demodex Mites in the Analysis Eye at Day 43	0.677; 0.173	—
SECONDARY Proportion of Participants Cured Based on a Composite Collarette and Erythema Score of 0 in the Analysis Eye at Day 43.	0.139; 0.01	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04475432). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.