Postoperative Safety Outcomes of Intraoperative Intracameral Preservative-Free Moxifloxacin Versus Levofloxacin

Postoperative Safety Outcomes in Patients Undergoing Routine Phacoemulsification Cataract Surgery With Intraoperative Intracameral Injection of Preservative-Free Moxifloxacin Versus Levofloxacin

Comparative safety study of intracameral levofloxacin versus moxifloxacin for postoperative infection prophylaxis

Study Overview

• Status: Completed
• Conditions: Cataract Senile; Endophthalmitis; Antibiotic Side Effect; Safety Issues
• Intervention / Treatment: Drug: Levofloxacin Ophthalmic; Drug: Moxifloxacin Ophthalmic

Detailed Description

Randomized clinical trial comparing corneal and retinal changes after intracameral levofloxacin or moxifloxacin administered at the end of surgery among eyes undergoing uncomplicated phacoemulsification.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 4

Contacts and Locations

Study Locations

• Philippines
  • MM
    • Makati City, MM, Philippines, 1209
      • Peregrine Eye and Laser Instittute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Eyes undergoing uncomplicated cataract surgery by phacoemulsification

Exclusion Criteria:

• Corneal opacities, corneal dystrophies, glaucoma, uveitis, retinopathy, optic neuropathy, concomitant infection (blepharitis, hordeolum, or conjunctivitis) or uncontrolled systemic disease and intraoperative complications that may affect visual outcomes were excluded from the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intracameral levofloxacin; 0.5% unpreserved solution	Drug: Levofloxacin Ophthalmic; 0.1 ml of unpreserved 0.5% levofloxacin
Experimental: Intracameral moxifloxacin; 0.5% unpreserved solution	Drug: Moxifloxacin Ophthalmic; 0.1 ml of unpreserved 0.5% moxifloxacin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial Cell Count	Change in endothelial cell count as measured by specular microscopy	3 months
Central Retina Thickness	Change in central retinal thickness as measured by spectral domain optical coherence tomography	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Onset of Adverse events following intervention	3 months

Collaborators and Investigators

• Sponsor: Peregrine Eye and Laser Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Actual): April 28, 2018
• Study Completion (Actual): April 28, 2018

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 21, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: prophylaxis; cataract surgery; levofloxacin; moxifloxacin; endophthalmitis
• Additional Relevant MeSH Terms: Infections; Eye Diseases; Lens Diseases; Eye Infections; Cataract; Endophthalmitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Moxifloxacin; Levofloxacin; Ofloxacin
• Other Study ID Numbers: 20180101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No