None listed
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of a new eye drop, 0.25% TP-03, for the treatment of eyelid inflammation due to a parasitic (Demodex) infestation compared to vehicle control. Study hypothesis: Treatment with TP-03 will result in a significantly greater proportion of participants with Grade 0 cylindrical dandruff and with their Demodex infestation eradicated at Day 42 compared to the vehicle control. Any ocular irritation experienced will be mild and similar to the vehicle control in frequency and severity.
Interventions
One drop of 0.25% TP-03 topical ophthalmic preparation administered twice daily to both eyes for 42 days. At every follow-up visit, the site will ask the participant to evaluate drop comfort to help assess compliance. At the Day 42 visit, participants will be asked to return the eye drop bottle.
Sponsors
Roberto González Salinas, MD
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must meet all of the following criteria in at least one eye: - More than 10 cylindrical dandruff present on the upper lid - Mild to severe upper eyelid margin erythema - Average Demodex density, upper and lower eyelids combined, of 1.5 mites or more per eyelash
Exclusion criteria
- Systemic or topical antibacterial, antiparasitic or anti-inflammatory steroid treatment within the last 14 days - Topical tea tree oil or hypochlorous acid treatment of the ophthalmic area within the last 14 days - The 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
Outcome results
None listed