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Evaluation of Gatifloxacin in treatment of bacterial corneal ulcers

Evaluation of efficacy of gatifloxacin (0.3%) in the treatment of non-perforated bacterial corneal ulcers

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/05/005781
Enrollment
200
Registered
2015-05-18
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: H160- Corneal ulcer Health Condition 2: null- Patients with moderate corneal ulcers between 2mm to 8mm

Interventions

Intervention1: Gatifloxacin 0.3 % eye drops: Route is topical. Dose is 0.3 %. The dosage schedule was as follows. For the first 72 hours, antibiotics were given every hour, day and night. After 72 hou

Sponsors

RPC AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Bacterial corneal ulcers measuring 2 to 8 mm giving written informed consent.

Exclusion criteria

Exclusion criteria: Bacterial corneal ulcers measuring less than 2 mm or more than 8 mm. Patients with suspected fungal, viral, or acanthamoeba ulcers and patients with known allergy to fluoroquinolones, aminoglycosides, penicillins, or cephalosporins were excluded from the study. Pregnant and lactating women and patients younger than 12 years also were excluded from the study.

Design outcomes

Primary

MeasureTime frame
Healing was defined as closure of the epithelial defect with disappearance of the stromal infiltrates at or before 3 months. Clinical response to medication was poor if the ulcer size remained the same or increased for 72 hours. If the patientâ??s keratitis worsened, the treatment code was broken, and the patient was administered a treatment regimen deemed fit by the investigator. Timepoint: Time point will be 3 months. Healing was defined as closure of the epithelial defect with disappearance of the stromal infiltrates at or before 3 months. Clinical response to medication was poor if the ulcer size remained the same or increased for 72 hours. If the patientâ??s keratitis worsened, the treatment code was broken, and the patient was administered a treatment regimen deemed fit by the investigator.

Secondary

MeasureTime frame
Final best-corrected visual acuity and resolution of infiltrates.Timepoint: 3 months

Countries

India

Contacts

Public ContactNamrata Sharma

Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS

namrata.sharma@gmail.com9810856988

Outcome results

None listed

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