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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Microbial Disease, Cataract Senile

Intervention / Treatment
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* Drug: Besifloxacin Ophthalmic
* Drug: Hydroxypropyl Methylcellulose Ophthalmic Ophthalmic Solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Besifloxacin<br>1 DROP 4 TIMES A DAY FOR 3 DAYS PRIOR SURGERY | Drug: Besifloxacin Ophthalmic<br>* Prophylaxis for endophthalmitis<br>* Other names: Besivance ophthalmic suspension 0.6%;|
| Placebo Comparator: Hydroxypropyl methylcellulose<br>1 DROP 4 TIMES A DAY FOR 3 DAYS PRIOR SURGERY | Drug: Hydroxypropyl Methylcellulose Ophthalmic Ophthalmic Solution<br>* Placebo<br>* Other names: Artelac eye drops;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Besifloxacin, prophylaxis, cataract surgery