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OpenTrials
Completed

NCT Number: NCT05413980

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

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

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Ahmedabad, Gujarat, India

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moxifloxacin hydrochloride ophthalmic solution

Other

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.

Primary outcomes

  1. Post-op endophthalmitis rate up to Day 14

    Time frame: Up to Day 14 after surgery

    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

Secondary outcomes

  1. Number of patients with diagnosis of suspected endophthalmitis using microbiological culture and Gram stain of aqueous and vitreous fluids

    Time frame: Day 1, Day 7, Day 14 after surgery

    Number of patients with diagnosis of suspected endophthalmitis using microbiological culture and Gram stain of aqueous and vitreous fluids to be collected

  2. Number of patients assessed for infection using 4 clinical signs post-surgery

    Time frame: Day 1, Day 7, Day 14 after 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.

  3. Number and proportion of patients with ocular adverse events (AEs) after surgery

    Time frame: Up to Day 16 after surgery

    Number and proportion of patients with ocular adverse events (AEs) after surgery to be collected

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 10, 2022
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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