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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05413980

Collaborator

(none)

102

Enrollment

4.7

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Post Operative Endophthalmitis	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 Design

Study Type:

Observational

Anticipated Enrollment :

102 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official 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

Anticipated Study Start Date :

Aug 13, 2022

Anticipated Primary Completion Date :

Jan 2, 2023

Anticipated Study Completion Date :

Jan 2, 2023

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Post-op endophthalmitis rate up to Day 14 [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 Outcome Measures

Number of patients with diagnosis of suspected endophthalmitis using microbiological culture and Gram stain of aqueous and vitreous fluids [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
Number of patients assessed for infection using 4 clinical signs post-surgery [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.
Number and proportion of patients with ocular adverse events (AEs) after surgery [Up to Day 16 after surgery]
Number and proportion of patients with ocular adverse events (AEs) after surgery to be collected

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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