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

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

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Key information

Conditions

Microbial Disease Cataract Senile

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Institute of Ophthalmology, Conde de Valenciana Foundation

Mexico City, 06800, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects over 18 years of age scheduled for cataract surgery in the established study period.
Subjects physically and mentally capable of applying the eye drops or having a person available to help in the correct administration of the eye drops 4 times a day.

Exclusion criteria

- Active eye infection (bacterial, viral, fungal or parasitic) such as blepharitis and / or conjunctivitis.
Known allergy or any contraindication to the use of quinolones or any of the components of the drugs.

Treatment and study plan

Besifloxacin Ophthalmic

Drug

Prophylaxis for endophthalmitis

Other names: Besivance ophthalmic suspension 0.6%

Hydroxypropyl Methylcellulose Ophthalmic Ophthalmic Solution

Drug

Placebo

Other names: Artelac eye drops

Primary outcomes

Percentage of positive cultures before and after treatment in each arm

Time frame: Through study completion, an average of 1 year

A conjunctival cul-de-sac sample will be taken before starting treatment and before surgery, which will be cultured on 3 different media types: Blood, Chocolate and Sabouraud agar.

Sponsors and collaborators

Lead sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Sep 9, 2020
Registry last updated: Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed