Status:
COMPLETED
Effectiveness and Safety of 0.5% Moxifloxacin Hydrochloride Ophthalmic Solution in Perioperative Sterilization in Patients Undergoing Ophthalmic Surgery
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Post Operative Endophthalmitis
Eligibility:
All Genders
18-100 years
Brief Summary
This is a non-interventional, uncontrolled, prospective, multicenter, post marketing surveillance study.
Detailed Description
The study treatment i.e., 0.5% Moxifloxacin hydrochloride ophthalmic solution will be prescribed as per approved label; the assignment of the patient to the therapy will be decided within the current ...
Eligibility Criteria
Inclusion
- Male or female patients \> 18 years of age, who have been prescribed 0.5% Moxifloxacin drops preoperatively 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
- Patients with known history of hypersensitivity to fluoroquinolones
- 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
Key Trial Info
Start Date :
January 27 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2024
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT05413980
Start Date
January 27 2024
End Date
April 1 2024
Last Update
May 9 2024
Active Locations (9)
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1
Novartis Investigative Site
Ahmedabad, Gujarat, India, 380016
2
Novartis Investigative Site
Ahmedabad, Gujarat, India, 380052
3
Novartis Investigative Site
Kochi, Kerala, India, 682041
4
Novartis Investigative Site
Nagpur, Maharashtra, India, 441108