Effectiveness and Safety of 0.5% Moxifloxacin Hydrochloride Ophthalmic Solution in Perioperative Sterilization in Patients Undergoing Ophthalmic Surgery

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

This is a non-interventional, uncontrolled, prospective, multicenter, post marketing surveillance study.

Study Overview

• Status: Completed
• Conditions: Post Operative Endophthalmitis
• Intervention / Treatment: Other: Moxifloxacin hydrochloride ophthalmic solution

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 practice and the medical indication and will clearly be separated from the decision to include the patient in the study.

The treatment period for each patient will be maximum 17 days from start of Moxifloxacin treatment. Study visit will be 1 day prior to surgery, day of surgery (Day 0) and 1 (day of surgery / post surgery), 7, and 14 days post-op (Note: Since its non-interventional study, the eligibility confirmation can be 1 or 2 days prior to the surgery depending on investigator's discretion).

After the patients sign the informed consent, the patients will be advised to start with Moxifloxacin ophthalmic solutions 2 days prior to the surgery and will be advised to administer it 5 times a day. On the Day 0, day of the surgery, the patient will be instilled 1 drop of Moxifloxacin in the eye which will be operated prior to surgery and 1 drop twice post surgery. From Day 1 post surgery, patient will have 1 drop of Moxifloxacin instilled three times a day up to Day 14 (14 days after surgery). If there are any signs and symptoms of endophthalmitis, then at the investigator's discretion, Gram Stain & Culture assessment of aqueous & vitreous fluid may be performed post surgery on Days 1, 7, and 14.

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• India
  • Delhi, India, 110018
    • Novartis Investigative Site
  • Gujarat
    • Ahmedabad, Gujarat, India, 380016
      • Novartis Investigative Site
    • Ahmedabad, Gujarat, India, 380052
      • Novartis Investigative Site
  • Kerala
    • Kochi, Kerala, India, 682041
      • Novartis Investigative Site
  • Maharashtra
    • Nagpur, Maharashtra, India, 441108
      • Novartis Investigative Site
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600045
      • Novartis Investigative Site
  • Uttar Pradesh
    • Varanasi, Uttar Pradesh, India, 221010
      • Novartis Investigative Site
  • West Bengal
    • Kolkata, West Bengal, India, 700073
      • Novartis Investigative Site
    • Kolkata, West Bengal, India, 700106
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients that are to undergo ocular surgery and are to be treated with Moxifloxacin and have provided informed consent

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Moxifloxacin hydrochloride ophthalmic solution; patients prescribed with 0.5% Moxifloxacin hydrochloride ophthalmic solution during the perioperative (preoperative and postoperative) period of ophthalmic surgery.	Other: Moxifloxacin hydrochloride ophthalmic solution; Prospective observational study. There is no treatment allocation. Patients prescribed with 0.5% Moxifloxacin hydrochloride ophthalmic solution during the perioperative period of ophthalmic surgery are eligible to enroll into this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-op endophthalmitis rate up to Day 14	The post-op endophthalmitis rate = (No of patients in whom endophthalmitis occurred in post-op period up to Day 14/ no of enrolled patients) X 100	Up to Day 14 after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with diagnosis of suspected endophthalmitis using microbiological culture and Gram stain of aqueous and vitreous fluids	Number of patients with diagnosis of suspected endophthalmitis using microbiological culture and Gram stain of aqueous and vitreous fluids to be collected	Day 1, Day 7, Day 14 after surgery
Number of patients assessed for infection using 4 clinical signs post-surgery	To assess for infection using 4 clinical signs post-surgery: Drop in vision; Pain and redness; Swelling; Purulent discharge It will be recorded and measured as present or absent.	Day 1, Day 7, Day 14 after surgery
Number and proportion of patients with ocular adverse events (AEs) after surgery	Number and proportion of patients with ocular adverse events (AEs) after surgery to be collected	Up to Day 16 after surgery

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2024
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: safety; NIS; efficacy; postoperative; India; preoperative; endophthalmitis; Moxifloxacin Hydrochloride Ophthalmic Solution; Ophthalmic Surgery; Antibacterial Effectiveness; perioperative sterilization
• Additional Relevant MeSH Terms: Infections; Eye Diseases; Eye Infections; Endophthalmitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Pharmaceutical Solutions; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Ophthalmic Solutions
• Other Study ID Numbers: CUKG489C1IN01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO