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

Novartis

Status: Completed

Conditions: Post Operative Endophthalmitis

Treatments: Other: Moxifloxacin hydrochloride ophthalmic solution

Study type: Observational

Funder types: Industry

Identifiers

NCT05413980

CUKG489C1IN01

Details and patient eligibility

About

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

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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

Trial design

102 participants in 1 patient group

Moxifloxacin hydrochloride ophthalmic solution

Description:

patients prescribed with 0.5% Moxifloxacin hydrochloride ophthalmic solution during the perioperative (preoperative and postoperative) period of ophthalmic surgery.

Treatment:

Other: Moxifloxacin hydrochloride ophthalmic solution