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

Cataract Senile Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04542759
• Other study ID #: CI-004-215
• Status: Completed
• Phase: Phase 1
• Start date: January 2017
• Est. completion date: April 2017

Study information

• Verified date: September 2020
• Source: Instituto de Oftalmología Fundación Conde de Valenciana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Cataract Senile
• Microbial Disease

Intervention

Drug:
• Besifloxacin Ophthalmic
Prophylaxis for endophthalmitis
• Hydroxypropyl Methylcellulose Ophthalmic Ophthalmic Solution
Placebo

Locations

Country	Name	City	State
Mexico	Institute of Ophthalmology, Conde de Valenciana Foundation	Mexico, City	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Oftalmología Fundación Conde de Valenciana

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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