Anterior BlepharitisODYSSEYNCT07869498
Ocular Dysbiosis in Eyelid Disease
An observational study of Anterior Blepharitis, run by Brent Kramer at 5 sites in United States.
Trial summary
The goal of this observational study is to determine the presence and prevalence of fungal organisms in four distinct blepharitis populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Blepharitis
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- 7 Aug 2026to Mar 2027
- Phase
- Observational
- 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
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.
Who may be able to join
- 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
Who cannot join
- Active ocular infection requiring urgent treatment
- Topical or systemic antifungal treatment within past 3 months
- Severe ocular surface disease precluding sampling
- Immunocompromised states (optional exclusion depending on investigator judgement)
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, 5 recruiting
- Recruiting
The Eye Associates
Jacksonville, Florida, 32256
Jerry Robben, OD, 904-296-0098, jrobben@bowdeneye.com
- Recruiting
Pure Ophthalmic Research
Mint Hill, North Carolina, 28227
Aynsley Girardeau, OD, 980-209-9437, doctorag@minthilleye.com
- Recruiting
Kannarr Eye Care
Pittsburg, Kansas, 66762
Shane Kannarr, OD, 620-687-2845, skannarr@kannarreyecare.com
- Recruiting
CORE Inc.
Shelby, North Carolina, 28150
Patrick Vollmer, OD, 828-406-3878, vollmer@researchwithcore.com
- Recruiting
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
Brent Kramer, MD, 605-361-3937, brent.kramer@vancethompsonvision.com
About this study
Official title: Prevalence of Ocular Dysbiosis Across Distinct Blepharitis Phenotypes: A Multicenter Observational Natural History Study
The goal of this observational study is to determine the presence and prevalence of fungal organisms in four distinct blepharitis populations.
- Conditions
- Anterior Blepharitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects in each group with laboratory-confirmed fungal organisms
Reported as % positive per group
Measured: 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
Measured: Day -14 or Greater
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start7 Aug 2026
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- 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
- NCT07869498
- Sponsor's protocol ID
- NT-4-001 Part 1
- Acronym
- ODYSSEY
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Ocular Dysbiosis Across Distinct Blepharitis Phenotypes: A Multicenter Observational Natural History Study
- ClinicalTrials.gov ID
- NCT07869498
- Acronym / sponsor ID
- ODYSSEY / NT-4-001 Part 1
- Conditions
- Anterior Blepharitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Brent KramerUniversity, hospital or other
- Study start
- 7 Aug 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 9 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 observational study is to determine the presence and prevalence of fungal organisms in four distinct blepharitis populations.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Active ocular infection requiring urgent treatment
- Topical or systemic antifungal treatment within past 3 months
- Severe ocular surface disease precluding sampling
- Immunocompromised states (optional exclusion depending on investigator judgement)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of subjects in each group with laboratory-confirmed fungal organisms
Time frame: Day -14 or Greater
Reported as % positive per group
1 secondary outcome
Comparison of fungal prevalence
Time frame: Day -14 or Greater
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 9 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?
An observational study of 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 9 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.
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?
Percentage of subjects in each group with laboratory-confirmed fungal organisms (time frame: Day -14 or Greater). 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 9 Oct 2026.