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Clinical Trials/CTRI/2023/12/060575
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Pms

Investigators

Sponsor
ovartis Healthcare Private Limited

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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