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Understanding the role of 1.5% levofloxacin drops in eyes with bacterial keratitis

Comparison of high strength topical levofloxacin (1.5%) monotherapy with standard combination therapy for the management of bacterial keratitis: A Randomized controlled trial.â??

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/025981
Enrollment
200
Registered
2020-06-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H168- Other keratitis

Interventions

Intervention1: 1.5% levofloxacin drops: For the first 72 hours (Days 1,2,3)- One drop hourly during day and night For the next 72 hours (Days 4,5,6) â?? 2 hourly for next 7 days followed by tapering

Sponsors

Santen India Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Microbiologically proven bacterial keratitis 2. Size of ulcer ranging between 2-8mm 3. Patients willing to participate and follow up

Exclusion criteria

Exclusion criteria: a) Patients with age less than 18 years b) Mixed infections; concomitant fungal, viral or acanthamoeba infections c) Size of ulcer less than 2mm and more than 8 mm d) Impending perforation or presence of corneal perforation at the time of presentation e) Associated endophthalmitis f) Pregnant and lactating females g) Patient not willing to participate and follow up h) Patients with known allergy to fluoroquinolones, aminoglycosides and cephalosporins

Design outcomes

Primary

MeasureTime frame
faster healing and recovery timeTimepoint: assessment will be done at baseline, 3 days, 1 week, 2 weeks, 3 weeks and 5 weeks

Secondary

MeasureTime frame
faster healing and recoveryTimepoint: assessment will be done at baseline, 3 days, 1 week, 2 weeks, 3 weeks and 5 weeks

Countries

India

Contacts

Public ContactNamrata Sharma

Dr.R.P.Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi

namrata.sharma@gmail.com01126593144

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026