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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04542759

Enrollment

Registered

2020-09-09

Start date

2017-01-31

Completion date

2017-04-30

Last updated

2020-09-09

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

Conditions

Microbial Disease, Cataract Senile

Keywords

Besifloxacin, prophylaxis, cataract surgery

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.

Interventions

DRUGBesifloxacin Ophthalmic

Prophylaxis for endophthalmitis

DRUGHydroxypropyl Methylcellulose Ophthalmic Ophthalmic Solution

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026