Intrastromal Moxifloxacin as an Adjunctive Therapy in Recalcitrant Bacterial Keratitis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorMinia University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• 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

Disqualifiers

Fungal, viral, or acanthamoeba keratitis

Corneal perforation or impending perforation

Known hypersensitivity to fluoroquinolones

Pregnancy or lactation

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intrastromal moxifloxacin injection plus standard topical moxifloxacin therapy

    Drug

    Intrastromal injection of preservative-free moxifloxacin 0.5% using a 30-gauge needle under aseptic conditions.

  • Standard topical moxifloxacin therapy alone

    Drug

    Intensive topical moxifloxacin eye drops every 1-2 hours initially, tapered according to standard clinical protocol and response.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Intrastromal moxifloxacin injection plus standard topical moxifloxacin therapyExperimental treatment 1 intervention
Group B: Standard topical moxifloxacin therapy aloneExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

• Epithelial defect size(mm)

epithelial defect is measured by surgical caliper

Time frame
weekly for one month
2

Hypopyon height(mm).

Time frame
weekly for one month
3

Pain score on visual Analog scale (VAS, 1 - 10).

Time frame
weekly for one month
4

Best-corrected visual acuity (BCVA) (LogMAR or Snellen)

Time frame
weekly for one month

Other outcomes

Sponsors and contacts

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