Evaluation of Gatifloxacin in treatment of bacterial corneal ulcers

Phase 4

Conditions: Health Condition 1: H160- Corneal ulcerHealth Condition 2: null- Patients with moderate corneal ulcers between 2mm to 8mm

Registration Number: CTRI/2015/05/005781

Lead Sponsor: RPC AIIMS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br/ ><br>Timepoint: Time point will be 3 months. <br/ ><br>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. <br/ ><br>

Secondary Outcome Measures