ClinicalTrials.gg
RecruitingNCT07869498ODYSSEYUpdated Oct 9, 2026

Ocular Dysbiosis in Eyelid Disease

An observational study in Anterior Blepharitis, sponsored by Brent Kramer. Recruiting at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by Brent Kramer · Observational

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.
Updated Oct 9, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Anterior Blepharitis

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03

In context

Blepharitis

73 studies on the registry are indexed under Blepharitis; 9 are open to participants now.

Browse Blepharitis studies →

Lead sponsor

Brent Kramer is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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Inclusion criteria

  • Adults 18 years or older, able to provide
  • 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

Exclusion criteria

Exclusion Criteria:

  • Active ocular infection requiring urgent treatment
  • Topical or systemic antifungal treatment within past 3 months
  • Severe ocular surface disease precluding sampling
  • states (optional exclusion depending on investigator judgement)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

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

    Reported as % positive per group

    Time frame: Day -14 or Greater

Secondary outcomes

  1. Comparison of fungal prevalence

    * Collarette-positive vs collarette-negative subjects (across all cohorts) * History of seborrheic dermatitis vs no history as well as sub-groups * Pre- vs post-Xdemvy (lotilaner ophthalmic solution) * Post antibiotic/steroid vs treatment-naïve * Fungal burden (semi-quantitative) * Organism type (yeast vs filamentous fungi) * Correlation with clinical signs: Erythema, Scaling, Madarosis

    Time frame: Day -14 or Greater

07

Study locations

5 of 5 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07869498
Lead sponsor
Brent Kramer
Responsible party
Brent Kramer (MD, Vance Thompson Vision) — Sponsor-investigator
First posted
Oct 9, 2026
Start date
Aug 7, 2026
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Oct 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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