Ocular Dysbiosis in Eyelid Disease

NCT07869498 | Recruiting

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

Brief Summary

The goal of this observational study is to determine the presence and prevalence of fungal organisms in four distinct blepharitis populations.

Conditions

Anterior Blepharitis

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects in each group with laboratory-confirmed fungal organisms

  Reported as % positive per group

  Day -14 or Greater

Secondary Outcomes (1)

• Comparison of fungal prevalence

  Day -14 or Greater

Study Arms (4)

Group A - Treatment-Naïve, active blepharitis symptoms

No recent blepharitis treatment for previous 6 months, including warm compresses or lid scrubs; no history of seborrheic dermatitis (excluding seborrheic blepharitis)

Group B -History of Seborrheic Dermatitis and/or seborrheic blepharitis, active blepharitis symptoms

Subjects grouped into this arm may be treatment-naïve or have received previous treatment for blepharitis (including warm compresses or lid scrubs). Investigators will capture these details at screening to further elicit the etiology of potential fungal blepharitis.

Group C - Post-Xdemvy, active blepharitis symptoms

Completed Xdemvy ≥4 weeks prior; persistent symptoms. No history of seborrheic Dermatitis, excluding seborrheic blepharitis.

Group D - Post Antibiotic/Steroid, active blepharitis symptoms

History of topical antibiotic with or without steroid therapy for the treatment of blepharitis in the last 6 months; persistent symptoms. No history of seborrheic dermatitis, excluding seborrheic blepharitis.

Eligibility Criteria

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

Study Population

A total of 60 eyes from 60 subjects will be included in the study. Per group: 15 eyes from 15 subjects (continue run-in enrollment until 15 subjects per group have been reached) enrolled from approximately 6 sites around the US.

You may qualify if:

• Adults 18 years or older, able to provide informed consent
• Clinical diagnosis of symptomatic moderate-severe anterior blepharitis (VAS subject reported eye irritation greater than or equal to 40 (0-100 scale), VAS subject reported eye itchiness greater than or equal to 40 (0-100 scale))
• Willingness to undergo lash epilation / lid margin sampling
• If both eyes qualify for study, the worst eye will be enrolled into the study as determined by investigator's medical judgment

You may not qualify if:

• Active ocular infection requiring urgent treatment
• Topical or systemic antifungal treatment within past 3 months
• Severe ocular surface disease precluding sampling

Sponsors & Collaborators

• Brent Kramer: lead

Study Sites (5)

The Eye Associates

Jacksonville, Florida, 32256, United States

RECRUITING

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

RECRUITING

Pure Ophthalmic Research

Mint Hill, North Carolina, 28227, United States

RECRUITING

CORE Inc.

Shelby, North Carolina, 28150, United States

RECRUITING

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Eyelash or eyelid margin scraping samples will be collected for laboratory testing to determine fungal presence.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 9, 2026
• Study Start: August 7, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)