NCT02595359

Brief Summary

The aim of this study was to evaluate the efficacy and safety of the prophylactic effect of intracameral moxifloxacin for prevention of postcataract endophthalmitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_2

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, 2013

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2018

Completed
Last Updated

April 24, 2019

Status Verified

April 1, 2019

Enrollment Period

5.5 years

First QC Date

November 2, 2015

Last Update Submit

April 22, 2019

Conditions

Endophthalmitis

Keywords

endophthalmitisantibiotic therapycataract surgeryprevention

Outcome Measures

Primary Outcomes (1)

  • endothelial cell count

    6-month; 1 year; 2 years

Secondary Outcomes (1)

  • endophthalmitis incidence

    1 month

Study Arms (1)

moxifloxacin intracameral

EXPERIMENTAL

moxifloxacin injection given at conclusion of cataract intervention

Drug: Moxifloxacin

Interventions

MoxifloxacinDRUG

Moxifloxacin intracameral

Also known as: Vigamox
moxifloxacin intracameral

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of visually significant cataract

You may not qualify if:

  • Has known allergies to moxifloxacin
  • Has significant ocular co-morbidities in one or both eyes which may include (but is not limited to): advanced glaucoma, advanced or active macular degeneration, Fuchs corneal dystrophy, prior corneal transplantation, advanced diabetic eye disease, history of retinal detachment or any patient that would require billing a complex cataract procedure for any reason
  • Has a known history of a condition which causes an immuno-compromised host state

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UFPE Ophthalmology

Recife, Pernambuco, 50740600, Brazil

Location

MeSH Terms

Conditions

Endophthalmitis

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Eye InfectionsInfectionsEye Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Rodrigo Lira

    Prof

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 2, 2015

First Posted

November 3, 2015

Study Start

January 1, 2013

Primary Completion

June 20, 2018

Study Completion

June 20, 2018

Last Updated

April 24, 2019

Record last verified: 2019-04

Locations

BR(1)