Back to resultsEffect of Topical Besifloxacin on Ocular Surface Bacterial Microbiota Prior to Cataract Surgery
Primary Purpose
Microbial Disease, Cataract Senile
Status
Completed
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
Besifloxacin Ophthalmic
Hydroxypropyl Methylcellulose Ophthalmic Ophthalmic Solution
Sponsored by
About this trial
This is an interventional treatment trial for Microbial Disease focused on measuring Besifloxacin, prophylaxis, cataract surgery
Eligibility Criteria
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.
Sites / Locations
- Institute of Ophthalmology, Conde de Valenciana Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Besifloxacin
Hydroxypropyl methylcellulose
Arm Description
1 DROP 4 TIMES A DAY FOR 3 DAYS PRIOR SURGERY
1 DROP 4 TIMES A DAY FOR 3 DAYS PRIOR SURGERY
Outcomes
Primary Outcome Measures
Percentage of positive cultures before and after treatment in each arm
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04542759
First Posted
August 19, 2020
Last Updated
September 2, 2020
Sponsor
Instituto de Oftalmología Fundación Conde de Valenciana
1. Study Identification
Unique Protocol Identification Number
NCT04542759
Brief Title
Effect of Topical Besifloxacin on Ocular Surface Bacterial Microbiota Prior to Cataract Surgery
Official Title
Effect of Topical Besifloxacin on Ocular Surface Bacterial Microbiota Prior to Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Oftalmología Fundación Conde de Valenciana
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microbial Disease, Cataract Senile
Keywords
Besifloxacin, prophylaxis, cataract surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Besifloxacin
Arm Type
Active Comparator
Arm Description
1 DROP 4 TIMES A DAY FOR 3 DAYS PRIOR SURGERY
Arm Title
Hydroxypropyl methylcellulose
Arm Type
Placebo Comparator
Arm Description
1 DROP 4 TIMES A DAY FOR 3 DAYS PRIOR SURGERY
Intervention Type
Drug
Intervention Name(s)
Besifloxacin Ophthalmic
Other Intervention Name(s)
Besivance ophthalmic suspension 0.6%
Intervention Description
Prophylaxis for endophthalmitis
Intervention Type
Drug
Intervention Name(s)
Hydroxypropyl Methylcellulose Ophthalmic Ophthalmic Solution
Other Intervention Name(s)
Artelac eye drops
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Percentage of positive cultures before and after treatment in each arm
Description
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.
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Chavez-Mondragon, MD
Organizational Affiliation
Instutute of Ophthalmology "Conde de Valenciana"
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Ophthalmology, Conde de Valenciana Foundation
City
Mexico, City
State/Province
Mexico City
ZIP/Postal Code
06800
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Topical Besifloxacin on Ocular Surface Bacterial Microbiota Prior to Cataract Surgery
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