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Not Yet Recruiting
NCT07856680
Clinical Lid Eradication of Antifungal-Responsive FUNGUS Study
Conditions: Anterior Blepharitis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 60
Sponsor: Brent Kramer
Location: The Eye Associates Jacksonville Florida
Summary
The goal of this clinical trial is to learn if Natacyn works to reduce or eliminate laboratory-confirmed fungal organisms in subjects with fungal-positive blepharitis identified in a previous study. asthma in adults. It will also learn more about the safety of Natacyn. The main questions it aims to answer are:
Does Natacyn reduce or eliminate fungal presence? Does Natacyn cause a reduction in eye irritation and itchiness? What medical problems do participants have when using Natacyn?
Participants will:
Apply Natacyn 4 times a day for 21 days Visit the clinic once every week for checkups and tests Keep a diary of the number of times they apply Natacyn over the 21-day period
Eligibility Criteria
Inclusion Criteria:
* Age 18 years or more
* Clinical diagnosis of blepharitis
* Laboratory-confirmed fungal organisms from Part 1
* Willingness to comply with QID (4 times a day) dosing for 21 days
* For women of childbearing potential (WOCBP): willingness to use a highly effective method of contraception (combined hormonal contraception, progestogen-only hormonal contraception with ovulation inhibition, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, or sexual abstinence) from at least 14 days prior to first dose of Natacyn through 30 days after the last dose. WOCBP is defined as a woman who has experienced menarche and is not surgically sterile or postmenopausal (defined as 12 or more consecutive months of amenorrhea).
* Ability to provide informed consent
Exclusion Criteria:
* Antifungal therapy within 3 months
* Hypersensitivity to natamycin
* Active keratitis or severe ocular infection
* Pregnancy or breastfeeding
* Participation in another interventional ocular study
Source: ClinicalTrials.gov (NCT07856680). StuddyBuddy aggregates publicly available trial information.