Post Operative EndophthalmitisNCT05413980
Effectiveness and Safety of 0.5% Moxifloxacin Hydrochloride Ophthalmic Solution in Perioperative Sterilization in Patients Undergoing Ophthalmic Surgery
An observational study of Post Operative Endophthalmitis, run by Novartis Pharmaceuticals at 9 sites in India.
Trial summary
This is a non-interventional, uncontrolled, prospective, multicenter, post marketing surveillance study. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Post Operative Endophthalmitis
- What is being tested?
- Moxifloxacin hydrochloride ophthalmic solution
- How many people
- 102 participants
- Where
- 9 sitesIndia
- Study dates
- 27 Jan 2024to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients that are to undergo ocular surgery and are to be treated with Moxifloxacin and have provided informed consent
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
9 sites in 1 country.
9 sites in 1 country
India9 sites
Novartis Investigative Site
Ahmedabad, Gujarat, 380016
Novartis Investigative Site
Ahmedabad, Gujarat, 380052
Novartis Investigative Site
Chennai, Tamil Nadu, 600045
Novartis Investigative Site
Delhi, 110018
Novartis Investigative Site
Kochi, Kerala, 682041
Novartis Investigative Site
Kolkata, West Bengal, 700073
Novartis Investigative Site
Kolkata, West Bengal, 700106
Novartis Investigative Site
Nagpur, Maharashtra, 441108
Novartis Investigative Site
Varanasi, Uttar Pradesh, 221010
About this study
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
This is a non-interventional, uncontrolled, prospective, multicenter, post marketing surveillance study.
Read the 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.
- Conditions
- Post Operative Endophthalmitis
- Being tested
- Moxifloxacin hydrochloride ophthalmic solution
- Keywords
- Moxifloxacin Hydrochloride Ophthalmic Solution, Ophthalmic Surgery, Antibacterial Effectiveness, NIS, India, preoperative, postoperative, endophthalmitis, perioperative sterilization, efficacy, safety
- Medical subject headings
- Endophthalmitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin hydrochloride ophthalmic solutionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Moxifloxacin hydrochloride ophthalmic solution | patients prescribed with 0.5% Moxifloxacin hydrochloride ophthalmic solution during the perioperative (preoperative and postoperative) period of ophthalmic surgery. Receives: Other: Moxifloxacin hydrochloride ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to Day 14 after surgery
Secondary outcomes (3)
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
Measured: Day 1, Day 7, Day 14 after surgery
Number of patients assessed for infection using 4 clinical signs post-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.
Measured: 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
Measured: Up to Day 16 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start27 Jan 2024
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative EndophthalmitisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413980
- Sponsor's protocol ID
- CUKG489C1IN01
- Status last verified
- May 2024
- First submitted
- 7 Jun 2022
- Last updated
- 9 May 2024
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05413980
- Acronym / sponsor ID
- CUKG489C1IN01
- Conditions
- Post Operative Endophthalmitis
- Keywords
- Moxifloxacin Hydrochloride Ophthalmic Solution, Ophthalmic Surgery, Antibacterial Effectiveness, NIS, India, preoperative, postoperative, endophthalmitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2024 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 10 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moxifloxacin hydrochloride ophthalmic solution | – | Other: Moxifloxacin hydrochloride ophthalmic solutionpatients prescribed with 0.5% Moxifloxacin hydrochloride ophthalmic solution during the perioperative (preoperative and postoperative) period of ophthalmic surgery. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients that are to undergo ocular surgery and are to be treated with Moxifloxacin and have provided informed consent
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moxifloxacin hydrochloride ophthalmic solutionProspective 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. | Other | Moxifloxacin hydrochloride ophthalmic solution |
Primary outcome
Post-op endophthalmitis rate up to Day 14
Time frame: 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
3 secondary outcomes
Number of patients with diagnosis of suspected endophthalmitis using microbiological culture and Gram stain of aqueous and vitreous fluids
Time frame: Day 1, Day 7, Day 14 after surgery
Number of patients assessed for infection using 4 clinical signs post-surgery
Time frame: Day 1, Day 7, Day 14 after surgery
Number and proportion of patients with ocular adverse events (AEs) after surgery
Time frame: Up to Day 16 after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No
Related trials for Post Operative Endophthalmitis
Not yet recruiting
Intracameral Levofloxacin Versus Moxifloxacin After Cataract Surgery
Cataract, Postoperative Endophthalmitis
RecruitingObservational study
Vascular Changes Associated With Endophthalmitis.
Endophthalmitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Operative Endophthalmitis, run by Novartis Pharmaceuticals at 9 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-op endophthalmitis rate up to Day 14 (time frame: Up to Day 14 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.