Phase 3 N=412 Randomized Quadruple-blind Treatment

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

Blepharitis

Bottom Line

View on ClinicalTrials.gov: NCT04784091 ↗

Enrolled (actual)

412

Serious AEs

1.7%

Results posted

Dec 2023

Primary outcome: Primary: The Proportion of Participants Cured Based on Their Collarette Score of 0 for the Upper Eyelid. — 0.547; 0.122 Proportion cured

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: TP-03 (Drug); TP-03 Vehicle (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Tarsus Pharmaceuticals, Inc.
Primary completion: May 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY The Proportion of Participants Cured Based on Their Collarette Score of 0 for the Upper Eyelid.	0.547; 0.122	—
SECONDARY The Proportion of Participants With Their Demodex Mites Eradicated.	0.499; 0.14	—
SECONDARY The Proportion of Participants Cured Based on a Composite of Collarette Score and Erythema Score	0.187; 0.039	—
SECONDARY The Proportion of Participants Cured Based on Erythema Score.	0.303; 0.091	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04784091). 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.