Clinical Lid Eradication of Antifungal-Responsive FUNGUS Study

NCT07856680 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: NT-4-001 Part 2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief 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

Conditions

Anterior Blepharitis

Outcome Measures

Primary Outcomes (1)

• Change from baseline in VAS irritation, VAS itching, and VFQ25 from baseline to Day 21

  Participants will report on a Visual Analog Scale their eye irritation and itchiness levels, and complete the Visual Function Questionnaire 25 at each visit.

  From enrollment to the end of treatment at 21 days

Secondary Outcomes (5)

• Proportion of subjects with fungal eradication at Day 21, read counts below the pre-specified central-laboratory detection threshold on ITS-targeted amplicon sequencing

  From enrollment to the end of treatment at 21 days

• Change from baseline in lid margin erythema, graded on a 0-3 nonlinear scale (Saturn-1/2 precedent; Yeu 2023), assessed at Part 1 Visit (baseline), Day 7, Day 14, and Day 21.

  From enrollment to the end of treatment at 21 days

• Change in fungal burden

  From end of prevalence study to the end of treatment at 21 days

• Change in NGS fungal signal

  From end of prevalence study to the end of treatment at 21 days

• Correlation with clinical signs

  From enrollment to the end of treatment at 21 days

Study Arms (1)

CLEAR - Clinical Lid Eradication of Antifungal-Responsive FUNGUS Study

EXPERIMENTAL

Natacyn (natamycin ophthalmic suspension 5%) applied to affected eye 4 times a day (QID) for 21 days

Drug: NATACYN®

Interventions

NATACYN® DRUG

Natamycin 5% ophthalmic suspension (Natacyn®) is FDA-approved for the treatment of fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms (NATACYN US Prescribing Information). The route of administration in this study - application to the eye at a frequency of QID for 21 days - is consistent with the labeled dosing range for fungal blepharitis (one drop, 4 to 6 times daily).

CLEAR - Clinical Lid Eradication of Antifungal-Responsive FUNGUS Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Antifungal therapy within 3 months
• Hypersensitivity to natamycin
• Active keratitis or severe ocular infection
• Pregnancy or breastfeeding
• Participation in another interventional ocular study

Sponsors & Collaborators

• Brent Kramer: lead

Study Sites (5)

The Eye Associates

Jacksonville, Florida, 32256, United States

Location

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

Pure Ophthalmic Research

Mint Hill, North Carolina, 28227, United States

Location

CORE Inc.

Shelby, North Carolina, 28150, United States

Location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

MeSH Terms

Interventions

Natamycin

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Model Details: Participants are eligible based on lab confirmation of fungal presence and blepharitis symptoms in prevalent study.

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)