NCT04542759

Effect of Topical Besifloxacin on Ocular Surface Bacterial Microbiota Prior to Cataract Surgery

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Describe the efficacy of the use of topical besifloxacin in reducing the conjunctival microbiota as a prophylactic measure in patients scheduled for cataract surgery.

Detailed description

Randomized double-blind clinical trial. Study carried out in a single center between January and April 2017. 60 eyes were included that were randomly divided in a 1: 1 ratio into two groups. The first group received placebo (hydroxypropylmethylcellulose drops) while the second group received 0.6% besifloxacin drops four times a day for 3 days. All of them had a conjunctival cul-de-sac culture before and after treatment.

Conditions

• Microbial Disease
• Cataract Senile

Interventions

Type	Name	Description
DRUG	Besifloxacin Ophthalmic	Prophylaxis for endophthalmitis
DRUG	Hydroxypropyl Methylcellulose Ophthalmic Ophthalmic Solution	Placebo

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2020-09-09
• Last updated: 2020-09-09

Locations

1 site across 1 country: Mexico

Regulatory

• FDA-regulated drug study