CTRI/2023/12/060575
Not yet recruiting
Phase 4
A Non-randomized, Non-Interventional, Prospective, Multicenter, Post Marketing Surveillance Study to Assess the Antibacterial Effectiveness and Safety of 0.5% Moxifloxacin Hydrochloride Ophthalmic Solution in Perioperative (Preoperative and Postoperative) Sterilization in Patients Undergoing Ophthalmic Surgery - VIGAMOX
ovartis Healthcare Private Limited0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: H578- Other specified disorders of eye and adnexa
- Sponsor
- ovartis Healthcare Private Limited
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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