Study evaluating a new drug to treat participants with Demodex blepharitis (inflammation of the eyelids)

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2021
INTERVENTION: 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. Participants will be randomized 1:1 in the active and control arms and will use the study drug twice a day for 28 days. A computer‐generated block randomization schedule will be used to label the study drug and bottles will be assigned to participants on a consecutive basis. Participation in the study will last for up to 90 days post‐initiation of treatment. CONDITION: Eyelid inflammation due to a parasitic (Demodex) infestation ; Eye Diseases ; Dermatitis of eyelid due to Demodex species PRIMARY OUTCOME: 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 OUTCOME: Change in collarette grading measured using slit lamp biomicroscopy at baseline, 14, and 28 days 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
Epistemonikos ID: 114ae45865d64fe3e7cb36d360498fa03027022d
First added on: Aug 25, 2024