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

I

Instituto de Oftalmología Fundación Conde de Valenciana

Status and phase

Completed
Phase 1

Conditions

Cataract Senile
Microbial Disease

Treatments

Drug: Besifloxacin Ophthalmic
Drug: Hydroxypropyl Methylcellulose Ophthalmic Ophthalmic Solution

Study type

Interventional

Funder types

Other

Identifiers

NCT04542759
CI-004-215

Details and patient eligibility

About

Describe the efficacy of the use of topical besifloxacin in reducing the conjunctival microbiota as a prophylactic measure in patients scheduled for cataract surgery.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups, including a placebo group

Besifloxacin
Active Comparator group
Description:
1 DROP 4 TIMES A DAY FOR 3 DAYS PRIOR SURGERY
Treatment:
Drug: Besifloxacin Ophthalmic
Hydroxypropyl methylcellulose
Placebo Comparator group
Description:
1 DROP 4 TIMES A DAY FOR 3 DAYS PRIOR SURGERY
Treatment:
Drug: Hydroxypropyl Methylcellulose Ophthalmic Ophthalmic Solution

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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