Anterior BlepharitisPhase 4CLEARNCT07856680
Clinical Lid Eradication of Antifungal-Responsive FUNGUS Study
A Phase 4 study testing NATACYN® in people with Anterior Blepharitis, run by Brent Kramer at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Blepharitis
- What is being tested?
- NATACYN®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2026to Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Antifungal therapy within 3 months
- Hypersensitivity to natamycin
- Active keratitis or severe ocular infection
- Pregnancy or breastfeeding
- Participation in another interventional ocular study
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
The Eye Associates
Jacksonville, Florida, 32256
Jerry Robben, OD, 904-296-0098, jrobben@bowdeneye.com
Pure Ophthalmic Research
Mint Hill, North Carolina, 28227
Aynsley Girardeau, OD, 980-209-9437, doctorag@minthilleye.com
Kannarr Eye Care
Pittsburg, Kansas, 66762
Shane Kannarr, OD, 620-687-2845, skannarr@kannarreyecare.com
CORE Inc.
Shelby, North Carolina, 28150
Patrick Vollmer, OD, 828-406-3878, vollmer@researchwithcore.com
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
Brent Kramer, MD, 605-361-3937, brent.kramer@vancethompsonvision.com
About this study
Official title: Treatment of Fungal Blepharitis With Natacyn: A Prospective Interventional Study
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
- Being tested
- NATACYN®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: NATACYN® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Reported as mean change from baseline and as proportion of subjects achieving erythema cure (grade 0) at Day 21.
Measured: From enrollment to the end of treatment at 21 days
Change in fungal burden
Measured: From end of prevalence study to the end of treatment at 21 days
Change in NGS fungal signal
Measured: From end of prevalence study to the end of treatment at 21 days
Correlation with clinical signs
Measured: From enrollment to the end of treatment at 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior BlepharitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants are eligible based on lab confirmation of fungal presence and blepharitis symptoms in prevalent study.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brent Kramer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brent Kramer, Vance Thompson Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856680
- Sponsor's protocol ID
- NT-4-001 Part 2
- Acronym
- CLEAR
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Fungal Blepharitis With Natacyn: A Prospective Interventional Study
- ClinicalTrials.gov ID
- NCT07856680
- Acronym / sponsor ID
- CLEAR / NT-4-001 Part 2
- Conditions
- Anterior Blepharitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Brent KramerUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants are eligible based on lab confirmation of fungal presence and blepharitis symptoms in prevalent study.
| Arm | Type | Receives |
|---|---|---|
| CLEAR - Clinical Lid Eradication of Antifungal-Responsive FUNGUS Study | Experimental | Drug: NATACYN®Natacyn (natamycin ophthalmic suspension 5%) applied to affected eye 4 times a day (QID) for 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (5 listed)
- Antifungal therapy within 3 months
- Hypersensitivity to natamycin
- Active keratitis or severe ocular infection
- Pregnancy or breastfeeding
- Participation in another interventional ocular study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NATACYN®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). | Drug | CLEAR - Clinical Lid Eradication of Antifungal-Responsive FUNGUS Study |
Primary outcome
Change from baseline in VAS irritation, VAS itching, and VFQ25 from baseline to Day 21
Time frame: From enrollment to the end of treatment at 21 days
Participants will report on a Visual Analog Scale their eye irritation and itchiness levels, and complete the Visual Function Questionnaire 25 at each visit.
5 secondary outcomes
Proportion of subjects with fungal eradication at Day 21, read counts below the pre-specified central-laboratory detection threshold on ITS-targeted amplicon sequencing
Time frame: 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.
Time frame: From enrollment to the end of treatment at 21 days
Change in fungal burden
Time frame: From end of prevalence study to the end of treatment at 21 days
Change in NGS fungal signal
Time frame: From end of prevalence study to the end of treatment at 21 days
Correlation with clinical signs
Time frame: From enrollment to the end of treatment at 21 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NATACYN® in people with Anterior Blepharitis, run by Brent Kramer at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in VAS irritation, VAS itching, and VFQ25 from baseline to Day 21 (time frame: From enrollment to the end of treatment at 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.