A Phase 2 interventional study of Adjunctive Topical Fluorometholone (FML) 0.1% and Standard Topical Antibiotic Therapy in Keratitis Bacterial and Corneal Ulcer (Diagnosis), sponsored by Vishal Jhanji. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Vishal Jhanji · Phase 2, Interventional, and Treatment
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.
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).
63 studies on the registry are indexed under Corneal Ulcer; 8 are open to participants now.
This study's planned enrollment of 174 is above the median of 60 across 45 interventional studies indexed under Corneal Ulcer.
Browse Corneal Ulcer studies →Vishal Jhanji is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Ulcer severity classified as:
Completed microbiologic work-up including ≥ 1 of:
Exclusion Criteria:
Clinical or laboratory evidence of:
Current use of:
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.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard Topical Antibiotic Therapy + Fluorometholone
Drug: Adjunctive Topical Fluorometholone (FML) 0.1% · Drug: Standard Topical Antibiotic Therapy
Standard Topical Antibiotic Therapy Alone
Drug: Standard Topical Antibiotic Therapy
Adjunctive Topical Fluorometholone (FML) 0.1% will be used
Patients will be treated with antibiotics (Cefazolin, Tobramycin or Moxifloxacin) we per treating physician
Best Corrected Visual Acuity (BCVA)
BCVA (logMAR) at 3 months post-randomization in the study eye.
Time frame: From enrollment to 3 months
Visual Improvement
Change in BCVA from baseline to weeks 1 and 4, and 3 months.
Time frame: From enrollment (Day 1) to Week 1, Month 1, Month 3.
Time to re-epithelialization
Time to re-epithelialization
Time frame: From enrollment to 3 months
Intraocular Pressure (IOP)
IOP measurements at all follow-up visits.
Time frame: From enrollment (Day 1) to Day 3, 1 Week, 1 Month, 3 Months.
Complications
Progressive thinning or perforation; hypopyon development or increase; endophthalmitis; fibrin formation; or worsening infiltrate size or depth ≥50%.
Time frame: From enrollment to Month 3.
Plan to share: No — The data would be made available upon reasonable request.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2029, 38 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Fluorometholone
Vishal Jhanji