Recruiting

Observational Study

Sponsor:

Brent Kramer

Code:

NCT07869498

Conditions

Anterior Blepharitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT07869498

Start date

Aug 7, 2026

Status verified date

Sep, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Percentage of subjects in each group with laboratory-confirmed fungal organisms [ Time Frame: Day -14 or Greater ]

Central Contacts and Locations

Locations

The Eye Associates

Recruiting

Jacksonville, Florida, United States, 32256

Contacts

Jerry Robben, OD

904-296-0098jrobben@bowdeneye.com

Kannarr Eye Care

Recruiting

Pittsburg, Kansas, United States, 66762

Contacts

Shane Kannarr, OD

620-687-2845skannarr@kannarreyecare.com

Pure Ophthalmic Research

Recruiting

Mint Hill, North Carolina, United States, 28227

Contacts

Aynsley Girardeau, OD

980-209-9437doctorag@minthilleye.com

CORE Inc.

Recruiting

Shelby, North Carolina, United States, 28150

Contacts

Patrick Vollmer, OD

828-406-3878vollmer@researchwithcore.com

Vance Thompson Vision

Recruiting

Sioux Falls, South Dakota, United States, 57108

Contacts

Brent Kramer, MD

605-361-3937brent.kramer@vancethompsonvision.com

More Information

Sponsor

Brent Kramer

Last update posted

Oct 9, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Brent Kramer on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.