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This is a non-interventional, uncontrolled, prospective, multicenter, post marketing surveillance 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moxifloxacin hydrochloride ophthalmic solution | patients prescribed with 0.5% Moxifloxacin hydrochloride ophthalmic solution during the perioperative (preoperative and postoperative) period of ophthalmic surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-op endophthalmitis rate up to Day 14 | 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 | Up to Day 14 after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with diagnosis of suspected endophthalmitis using microbiological culture and Gram stain of aqueous and vitreous fluids | Number of patients with diagnosis of suspected endophthalmitis using microbiological culture and Gram stain of aqueous and vitreous fluids to be collected | Day 1, Day 7, Day 14 after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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patients that are to undergo ocular surgery and are to be treated with Moxifloxacin and have provided informed consent
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Ahmedabad | Gujarat | 380016 | India | ||
| Novartis Investigative Site |
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|
| Number of patients assessed for infection using 4 clinical signs post-surgery |
To assess for infection using 4 clinical signs post-surgery:
It will be recorded and measured as present or absent. |
| Day 1, Day 7, Day 14 after surgery |
| Number and proportion of patients with ocular adverse events (AEs) after surgery | Number and proportion of patients with ocular adverse events (AEs) after surgery to be collected | Up to Day 16 after surgery |
| Ahmedabad |
| Gujarat |
| 380052 |
| India |
| Novartis Investigative Site | Kochi | Kerala | 682041 | India |
| Novartis Investigative Site | Nagpur | Maharashtra | 441108 | India |
| Novartis Investigative Site | Chennai | Tamil Nadu | 600045 | India |
| Novartis Investigative Site | Varanasi | Uttar Pradesh | 221010 | India |
| Novartis Investigative Site | Kolkata | West Bengal | 700073 | India |
| Novartis Investigative Site | Kolkata | West Bengal | 700106 | India |
| Novartis Investigative Site | Delhi | 110018 | India |
| ID | Term |
|---|---|
| D009877 | Endophthalmitis |
| ID | Term |
|---|---|
| D015817 | Eye Infections |
| D007239 | Infections |
| D005128 | Eye Diseases |
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