A post marketing surveillance study of Moxifloxacin Hydrochloride solution to check its ability to prevent the growth or spread of bacteria & its safety in patient undergoing ophthalmic surgery.

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 - VIGAMOX

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2023/12/060575

Enrollment

102

Registered

2023-12-20

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H578- Other specified disorders of eye and adnexa

Interventions

Intervention1: NIL: NIL Intervention2: Moxifloxacin Hydrochloride Ophthalmic Solution 0.5%,: one drop 5 times a day 2 days prior to surgery & 3 times a day post surgery until day 14, Route- Topical Ey

Eligibility

Inclusion criteria

Inclusion criteria: Male or female patients > 18 years of age, who have been prescribed 0.5% Moxifloxacin drops preoperatively (2 days) 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

Exclusion criteria: Patients with known history of hypersensitivity to fluoroquinolones Novartis Confidential Page 14 Non-Interventional Study Protocol v00 CUKG489C1IN01 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

Design outcomes

Primary

Measure	Time frame
1. To measure the post-op endophthalmitis infection rateTimepoint: 1. To measure the post-op endophthalmitis infection rate upto day fourteen	—

Secondary

Measure	Time frame
To confirm endophthalmitis & assess clinical signs of other postoperative infections on Days 1, 7 and 14 after surgery.Timepoint: Diagnosis of suspected endophthalmitis patients using microbiological culture & Gram stain of aqueous & vitreous fluids To assess for infection using 4 clinical signs post-surgery: a. Drop in vision b. Pain and redness c. Swelling d. Purulent discharge To assess number and proportion of patients with ocular adverse events (AEs) after surgery	—

Measure

Time frame

To confirm endophthalmitis & assess clinical signs of other postoperative infections on Days 1, 7 and 14 after surgery.Timepoint: Diagnosis of suspected endophthalmitis patients using microbiological culture & Gram stain of aqueous & vitreous fluids To assess for infection using 4 clinical signs post-surgery: a. Drop in vision b. Pain and redness c. Swelling d. Purulent discharge To assess number and proportion of patients with ocular adverse events (AEs) after surgery

—

Countries

India

Contacts

Public ContactDr. Anup Thorat,

Novartis Healthcare Private Limited.

anup_vilas.thorat@novartis.com9702855895

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026