Study Evaluating a New Drug to Treat Participants with Eyelid Inflammation Related to a Parasite (Demodex)
Randomized, Controlled, Double-Blind, Parallel Trial to Evaluate the Safety and Efficacy of TP- 03 for the Treatment of Blepharitis Due to Demodex Infestation
Roberto González Salinas, MD
60 participants
Jan 8, 2020
Interventional
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria3
- 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
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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.
Locations(1)
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ACTRN12620000320954