A post marketing surveillance study of Moxifloxacin Hydrochloride solution to check its ability to prevent the growth or spread of bacteria & its safety in patient undergoing ophthalmic surgery.
- Conditions
- Health Condition 1: H578- Other specified disorders of eye and adnexa
- Registration Number
- CTRI/2023/12/060575
- Lead Sponsor
- ovartis Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Male or female patients > 18 years of age, who have been prescribed 0.5% Moxifloxacin drops preoperatively (2 days) and postoperatively for 2 weeks after ocular surgery
Patient or legally acceptable representative (LAR) willing to voluntarily provide signed informed consent for participation in the study
Patients with known history of hypersensitivity to fluoroquinolones
Novartis Confidential Page 14
Non-Interventional Study Protocol v00 CUKG489C1IN01
Patients with history of serious underlying ocular or systemic disease or complication before surgery
Patients diagnosed with an extraocular bacterial, viral, fungal infection prior to surgery
Patients who have been administered other topical antibacterial agents within 24 hours of Moxifloxacin administration or systemic antibacterial agents within 72 hours of Moxifloxacin administration
Patients who have planned to undergo cataract surgery in both eyes on same day
Patients who have participated in another clinical study within 30 days prior to the start of this study
Pregnant women/lactating mothers/ women suspected to be pregnant
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To measure the post-op endophthalmitis infection rateTimepoint: 1. To measure the post-op endophthalmitis infection rate upto day fourteen
- Secondary Outcome Measures
Name Time Method To confirm endophthalmitis & assess clinical signs of other postoperative infections on Days 1, 7 and 14 after surgery.Timepoint: Diagnosis of suspected endophthalmitis patients using microbiological culture & Gram stain of aqueous & vitreous fluids <br/ ><br>To assess for infection using 4 clinical signs post-surgery: <br/ ><br>a. Drop in vision <br/ ><br>b. Pain and redness <br/ ><br>c. Swelling <br/ ><br>d. Purulent discharge <br/ ><br>To assess number and proportion of patients with ocular adverse events (AEs) after surgery