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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Mexico City
      • Mexico, City, Mexico City, Mexico, 06800
        • Institute of Ophthalmology, Conde de Valenciana Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Besifloxacin
1 DROP 4 TIMES A DAY FOR 3 DAYS PRIOR SURGERY
Prophylaxis for endophthalmitis
Other Names:
  • Besivance ophthalmic suspension 0.6%
Placebo Comparator: Hydroxypropyl methylcellulose
1 DROP 4 TIMES A DAY FOR 3 DAYS PRIOR SURGERY
Placebo
Other Names:
  • Artelac eye drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Eduardo Chavez-Mondragon, MD, Instutute of Ophthalmology "Conde de Valenciana"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

August 19, 2020

First Submitted That Met QC Criteria

September 2, 2020

First Posted (Actual)

September 9, 2020

Study Record Updates

Last Update Posted (Actual)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 2, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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