Eyelid inflammation due to a parasitic (Demodex) infestation Eye Diseases Dermatitis of eyelid due to Demodex species
Conditions
Interventions
This study is intended to evaluate the safety and efficacy of TP-03, ophthalmic solution, 0.25% compared to vehicle control for the treatment of blepharitis due to Demodex infestation.
Sponsors
Roberto Gonzalez Salinas, MD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol 2. Participants must meet all of the following criteria in at least one eye: 2.1. More than 10 collarettes present on the upper lid 2.2. Mild to severe lid margin erythema 2.3. Average Demodex density of 1.5 or more mites per lash 3. Aged =18 years
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. Use of lid hygiene products (eyelid scrubs) in the last 14 days or unwilling to forego the use of lid hygiene products during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Demodex density calculated as the number of mites per lash measured using lash epilation and mite counting via microscope at baseline and 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in collarette grading measured using slit lamp biomicroscopy at baseline, 14, and 28 days | — |
Countries
Mexico
Outcome results
None listed