An interventional study of Intrastromal moxifloxacin injection plus standard topical moxifloxacin therapy and Standard topical moxifloxacin therapy alone in Bacterial Keratitis, Recalcitrant Infectious Keratitis and Corneal Ulcer, sponsored by Minia University. Recruiting at 1 site in Egypt. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Minia University · Not applicable, Interventional, and Treatment
Bacterial keratitis is a potentially sight-threatening corneal infection that is commonly treated with intensive topical antibiotics. Despite appropriate therapy, some cases show inadequate clinical response, particularly when the infection involves the deep corneal stroma. Limited penetration of topical antibiotics into deeper corneal layers may contribute to treatment failure in these recalcitrant cases.
Intrastromal antibiotic injection is a targeted drug-delivery approach that allows high local antimicrobial concentrations directly at the site of infection. Moxifloxacin is a broad-spectrum fluoroquinolone with proven efficacy in bacterial keratitis and favorable corneal tissue penetration. However, evidence regarding the clinical benefit and safety of intrastromal moxifloxacin as an adjunctive treatment remains limited.
This randomized controlled trial aims to evaluate the efficacy and safety of intrastromal moxifloxacin injection as an adjunct to standard topical moxifloxacin therapy compared with topical therapy alone in patients with recalcitrant bacterial keratitis. The primary outcome is time to complete clinical resolution of infection. Secondary outcomes include visual acuity improvement, ulcer healing rate, need for additional interventions, and treatment-related complications.
63 studies on the registry are indexed under Corneal Ulcer; 8 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 45 interventional studies indexed under Corneal Ulcer.
Browse Corneal Ulcer studies →Minia University is the lead sponsor of 370 studies on the registry; 117 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Age ≥ 18 years
Exclusion Criteria
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intrastromal injection of preservative-free moxifloxacin 0.5% using a 30-gauge needle under aseptic conditions.
Drug: Intrastromal moxifloxacin injection plus standard topical moxifloxacin therapy
• Intensive topical moxifloxacin eye drops every 1-2 hours initially, tapered according to standard clinical protocol and response
Drug: Standard topical moxifloxacin therapy alone
Intrastromal injection of preservative-free moxifloxacin 0.5% using a 30-gauge needle under aseptic conditions.
Intensive topical moxifloxacin eye drops every 1-2 hours initially, tapered according to standard clinical protocol and response.
Time to complete clinical resolution(days)
Time to complete clinical resolution, defined as corneal re-epithelialization with disappearance of stromal infiltrate and anterior chamber reaction.
Time frame: weekly till complete healing
• Epithelial defect size(mm)
epithelial defect is measured by surgical caliper
Time frame: weekly for one month
Hypopyon height(mm).
Time frame: weekly for one month
Pain score on visual Analog scale (VAS, 1 - 10).
Time frame: weekly for one month
Best-corrected visual acuity (BCVA) (LogMAR or Snellen)
Time frame: weekly for one month
Complications (perforation, thinning, endophthalmitis).
Time frame: after 3 months
Plan to share: Undecided — (IPD) will not be shared because the study was not designed with a data-sharing framework, and participants did not provide explicit consent for secondary use or external sharing of their individual-level data. In addition, sharing IPD may pose potential risks to participant privacy, even after de-identification, particularly in single-center studies with limited sample sizes. Current clinical trial registration requirements mandate transparency regarding data-sharing intentions but do not obligate investigators to share IPD. Therefore, the decision not to share IPD is made in accordance with ethical standards, privacy regulations, and applicable registry policies.
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