NCT04542759

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

3 months

First QC Date

August 19, 2020

Last Update Submit

September 2, 2020

Conditions

Microbial DiseaseCataract Senile

Keywords

Besifloxacinprophylaxiscataract surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Besifloxacin

ACTIVE COMPARATOR

1 DROP 4 TIMES A DAY FOR 3 DAYS PRIOR SURGERY

Drug: Besifloxacin Ophthalmic

Hydroxypropyl methylcellulose

PLACEBO COMPARATOR

1 DROP 4 TIMES A DAY FOR 3 DAYS PRIOR SURGERY

Drug: Hydroxypropyl Methylcellulose Ophthalmic Ophthalmic Solution

Interventions

Besifloxacin OphthalmicDRUG

Prophylaxis for endophthalmitis

Also known as: Besivance ophthalmic suspension 0.6%
Besifloxacin
Hydroxypropyl Methylcellulose Ophthalmic Ophthalmic SolutionDRUG

Placebo

Also known as: Artelac eye drops
Hydroxypropyl methylcellulose

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Ophthalmology, Conde de Valenciana Foundation

Mexico City, Mexico City, 06800, Mexico

Location

Study Officials

  • Eduardo Chavez-Mondragon, MD

    Instutute of Ophthalmology "Conde de Valenciana"

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2020

First Posted

September 9, 2020

Study Start

January 1, 2017

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

September 9, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)