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

Phase 1

Completed

• Conditions: Cataract Senile; Microbial Disease
• Interventions: Drug: Hydroxypropyl Methylcellulose Ophthalmic Ophthalmic Solution; Drug: Besifloxacin Ophthalmic

• Registration Number: NCT04542759
• Lead Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana

Brief 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.

Study Timeline

• Study Start: 2017-01
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Study First Submitted: 2020-08-19
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-02
• Last Update Submitted: 2020-09-02
• Study First Posted: 2020-09-09
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydroxypropyl methylcellulose	Hydroxypropyl Methylcellulose Ophthalmic Ophthalmic Solution	1 DROP 4 TIMES A DAY FOR 3 DAYS PRIOR SURGERY
Besifloxacin	Besifloxacin Ophthalmic	1 DROP 4 TIMES A DAY FOR 3 DAYS PRIOR SURGERY

Primary Outcome Measures

Name	Time	Method
Percentage of positive cultures before and after treatment in each arm	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.

Trial Locations

Locations (1)

Institute of Ophthalmology, Conde de Valenciana Foundation; 🇲🇽 Mexico, City, Mexico City, Mexico