Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07308938

Fluorometholone Study

The investigators seek to determine whether adjunctive topical fluorometholone (FML) improves best-corrected visual acuity (BCVA) at 3 months in patients with bacterial corneal ulcers compared with standard topical antibiotic therapy alone.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UPMC Vision Institute

Pittsburgh, Pennsylvania, 15219, United States

Location contact

Alex Mammen, MD

SUB_INVESTIGATOR

Prakash Gaurav, MD

SUB_INVESTIGATOR

Rose Carla Aubourg, BA

CONTACT

[email protected]

412-642-7888

Sabrina Mukhtar, MD

SUB_INVESTIGATOR

Sarah Waters

CONTACT

[email protected]

412-642-7888

Vishal Jhanji, MD

PRINCIPAL_INVESTIGATOR

About this study

In this prospective, randomized, parallel-group clinical cohort study, the investigators seek to determine whether adjunctive topical fluorometholone (FML) improves best-corrected visual acuity (BCVA) at 3 months in patients with bacterial corneal ulcers compared with standard topical antibiotic therapy alone. The primary objective is to compare the mean 3-month BCVA (logMAR) between the intervention arm (standard topical antibiotic therapy + FML 0.1%) and a control arm (standard topical antibiotic therapy alone).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged ≥ 18 years.
  • Clinical diagnosis of a bacterial corneal ulcer based on slit-lamp examination.
  • Ulcer severity classified as:
  • Mild: Diameter ≤ 3 mm AND stromal depth ≤ 1/3 thickness.
  • Moderate: Diameter >3-6 mm and/or stromal depth > 1/3-2/3.
  • Severe: Diameter >6 mm and/or stromal depth >2/3.
  • Completed microbiologic work-up including ≥ 1 of:
  • Corneal culture, or
  • PCR testing.
  • Received ≥ 48-96 hours of empiric topical antibiotic therapy prior to randomization (fluoroquinolone monotherapy or fortified cefazolin/tobramycin based on standard of care).
  • Able and willing to provide informed consent and comply with study visits.

Exclusion criteria

  • Clinical or laboratory evidence of:
  • Herpes simplex keratitis.
  • Acanthamoeba keratitis.
  • Fungal keratitis (positive smear, culture or PCR).
  • Corneal perforation or imminent perforation at presentation.
  • Current use of:
  • Topical corticosteroids in the study eye, or
  • Systemic corticosteroids during this ulcer episode.
  • History of steroid-responsive glaucoma or uncontrolled intraocular pressure (IOP).

Treatment and study plan

Adjunctive Topical Fluorometholone (FML) 0.1%

Drug

Adjunctive Topical Fluorometholone (FML) 0.1% will be used

Standard Topical Antibiotic Therapy

Drug

Patients will be treated with antibiotics (Cefazolin, Tobramycin or Moxifloxacin) we per treating physician

Primary outcomes

  1. Best Corrected Visual Acuity (BCVA)

    Time frame: From enrollment to 3 months

    BCVA (logMAR) at 3 months post-randomization in the study eye.

Secondary outcomes

  1. Visual Improvement

    Time frame: From enrollment (Day 1) to Week 1, Month 1, Month 3.

    Change in BCVA from baseline to weeks 1 and 4, and 3 months.

  2. Time to re-epithelialization

    Time frame: From enrollment to 3 months

    Time to re-epithelialization

  3. Intraocular Pressure (IOP)

    Time frame: From enrollment (Day 1) to Day 3, 1 Week, 1 Month, 3 Months.

    IOP measurements at all follow-up visits.

  4. Complications

    Time frame: From enrollment to Month 3.

    Progressive thinning or perforation; hypopyon development or increase; endophthalmitis; fibrin formation; or worsening infiltrate size or depth ≥50%.

Study contacts

Contact information is provided by the study sponsor or research team.

Rose Carla Aubourg, BA

CONTACT

[email protected]

412-642-7888

Sarah Waters

CONTACT

[email protected]

412-642-7888

Sponsors and collaborators

Lead sponsor

Vishal Jhanji

Other

Collaborators

  • University of Pittsburgh Medical Center

Registry information

Official study title

Trial of Topical Fluorometholone as Adjunctive Therapy for Bacterial Corneal Ulcers

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Dec 30, 2025
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.