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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-27

Study Completion Date

2024-04-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Post Operative Endophthalmitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Moxifloxacin hydrochloride ophthalmic solution

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

Moxifloxacin hydrochloride ophthalmic solution

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No