Blepharitis due to Demodex infestation Infections and Infestations
Conditions
Interventions
Participants will instill one drop of the active treatment solution (TP-03, 0.25%) in each eye, twice a day, morning and evening for 42 days.
Participants will be seen for follow-up v
Sponsors
Tarsus Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects greater or equal to 18 years of age with blepharitis due to Demodex infestation 2. Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol 3. Participants must meet the following criteria in at least one eye: Have more than 10 collarettes present on the upper lid or an average Demodex density, upper and lower eyelids combined, of at least 1.5 mites per lash
Exclusion criteria
Exclusion criteria: 1. Systemic or topical antibacterial, antiparasitic or anti-inflammatory steroid treatment within the last 14 days 2. Topical tea tree oil or hypochlorous acid treatment of the ophthalmic area within the last 14 days 3. The use of lid hygiene products (lid scrubs) within the last 14 days or unwilling to forego the use of lid hygiene products during the study treatment phase 4. Contact lens wear within the last 7 days or unwilling to forego contact lens wear during the study treatment phase
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Signs of blepharitis measured using collarette grading at Days 7, 14, 28, and 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| Demodex density measured by lash epilation and mite counting via microscope at Days 7, 14, 28, and 42 | — |
Countries
Mexico
Outcome results
None listed