Clinical trial NCT05413980: Effectiveness and Safety of 0.5% Moxifloxacin Hydrochloride Ophthalmic Solution in Perioperative Sterilization in Patients Undergoing Ophthalmic Surgery
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Operative Endophthalmitis
Keywords: Moxifloxacin Hydrochloride Ophthalmic Solution
Ophthalmic Surgery
Antibacterial Effectiveness
NIS
India
preoperative
postoperative
endophthalmitis
perioperative sterilization
efficacy
safety
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-06-10
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-op endophthalmitis rate up to Day 14
timeFrame: Up to Day 14 after surgery
Secondary outcomes:
measure: Number of patients with diagnosis of suspected endophthalmitis using microbiological culture and Gram stain of aqueous and vitreous fluids
timeFrame: Day 1, Day 7, Day 14 after surgery
measure: Number of patients assessed for infection using 4 clinical signs post-surgery
timeFrame: Day 1, Day 7, Day 14 after surgery
measure: Number and proportion of patients with ocular adverse events (AEs) after surgery
timeFrame: Up to Day 16 after surgery
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Novartis Investigative Site
state: Gujarat
city: Ahmedabad
country: India
facility: Novartis Investigative Site
state: Gujarat
city: Kochi
country: India
facility: Novartis Investigative Site
state: Kerala
city: Nagpur
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Chennai
country: India
facility: Novartis Investigative Site
state: Tamil Nadu
city: Varanasi
country: India
facility: Novartis Investigative Site
state: Uttar Pradesh
city: Kolkata
country: India
facility: Novartis Investigative Site
state: West Bengal
city: Kolkata
country: India
facility: Novartis Investigative Site
state: West Bengal
city: Delhi
country: India
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: