Intrastromal moxifloxacin added to topical treatment for stubborn bacterial corneal ulcers
Official title: Intrastromal Moxifloxacin as an Adjunctive Therapy in Recalcitrant Bacterial Keratitis
Run by Minia University · NCT07394257 · Data updated 2026-11-12
This will test whether injecting moxifloxacin into the cornea, alongside standard moxifloxacin eye drops, helps adults whose bacterial keratitis hasn't improved after 48–72 hours of intensive drops.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Minia University Academic / other |
| Locations | 1 site (Minya) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | April 1, 2026 |
| Study ends | October 1, 2026 |
| Registry record updated | September 10, 2026 |
| Trial ID | NCT07394257 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with microbiology-confirmed bacterial keratitis that shows no significant improvement after 48–72 hours of intensive topical antibiotic therapy, who are not pregnant and have no corneal perforation, are ideal candidates.
✕Probably not a fit
Patients with fungal, viral, or acanthamoeba keratitis, corneal perforation or impending perforation, known fluoroquinolone allergy, pregnancy or lactation, immunocompromise, or prior intrastromal/intracameral injection for the same episode are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial compares intrastromal moxifloxacin injection plus standard topical moxifloxacin versus topical moxifloxacin alone for recalcitrant bacterial keratitis. Eligible adults have culture-confirmed bacterial keratitis with little or no clinical improvement after 48–72 hours of intensive topical therapy. The intrastromal approach delivers high antibiotic concentrations directly into the deep corneal stroma where topical drops may not penetrate well. Primary outcomes will focus on clinical improvement and safety of the adjunctive injection compared with standard care.
Why it matters
Potential benefit: If successful, the adjunctive intrastromal injection could speed resolution of deep corneal infections and reduce the risk of vision loss by delivering higher local antibiotic levels.
How similar studies have gone: Intrastromal antibiotic injections have been reported in case series and small studies with some success for recalcitrant keratitis, but randomized evidence specifically for intrastromal moxifloxacin is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Age ≥ 18 years * Clinical diagnosis of bacterial keratitis confirmed by corneal scraping and microbiology * Recalcitrant keratitis defined as no significant clinical improvement after 48-72 hours of intensive topical antibiotic therapy * Ability to provide written informed consent Exclusion Criteria * Fungal, viral, or acanthamoeba keratitis * Corneal perforation or impending perforation * Known hypersensitivity to fluoroquinolones * Pregnancy or lactation * Immunocompromised state or current systemic immunosuppressive therapy * Previous intrastromal or intracameral antibiotic injection for the same episode
Where it's running
-
Mahmoud Ramadan Amer
Minya, Egypt Recruiting
Study contacts
- Study coordinator: Mahmoud Ramadan Amer, MD
- Email: mahmoud3mer89@gmail.com
- Phone: 0201068005575
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.