Randomized, Controlled, Multicenter, Double-Masked, Parallel, Phase 3 Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis

TRS-010

The purpose of this study is to compare the safety and efficacy of TP-03, an eyedrop, to its vehicle control for the treatment of blepharitis due to Demodex, a microscopic mite frequently found in human hair follicles.

2021-04-29

2022-05-09

2022-05-09

Completed

Early phase I

412

Inclusion Criteria: * Be willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol * Meet all of the following criteria in at least one eye: Have more than 10 lashes with collarettes present on the upper lid; have at least mild erythema of the upper eyelid margin; have an average Demodex density, upper and lower eyelids combined, of 1.5 or more mites per lash Exclusion Criteria: * Have used lid hygiene products within 14 days of Screening or unwilling to forego the use of lid hygiene products during the study * Have used a prostaglandin analogue to promote eyelash growth within 30 days of Screening or any plans to initiate treatment during the study * Have used artificial eyelashes or eyelash extensions within 7 days of Screening or be unwilling to forego their use during the study * Be pregnant or lactating at the time of Screening

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Active arm: TP-03, 0.25% Control arm: Vehicle of TP-03', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Treatment assignment will be unknown to the study participant, investigators and site staff performing study assessments.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 412, 'type': 'ACTUAL'}}

2023-12-21