- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04542759
Effect of Topical Besifloxacin on Ocular Surface Bacterial Microbiota Prior to Cataract Surgery
September 2, 2020 updated by: Instituto de Oftalmología Fundación Conde de Valenciana
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
Status
Completed
Conditions
Intervention / Treatment
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:
|
Placebo Comparator: Hydroxypropyl methylcellulose
1 DROP 4 TIMES A DAY FOR 3 DAYS PRIOR SURGERY
|
Placebo
Other Names:
|
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CI-004-215
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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