NCT04403334

Brief Summary

Comparative safety study of intracameral levofloxacin versus moxifloxacin for postoperative infection prophylaxis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2018

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

May 21, 2020

Last Update Submit

May 21, 2020

Conditions

Cataract SenileEndophthalmitisAntibiotic Side EffectSafety Issues

Keywords

levofloxacinmoxifloxacinprophylaxisendophthalmitiscataract surgery

Outcome Measures

Primary Outcomes (2)

  • Endothelial Cell Count

    Change in endothelial cell count as measured by specular microscopy

    3 months

  • Central Retina Thickness

    Change in central retinal thickness as measured by spectral domain optical coherence tomography

    3 months

Secondary Outcomes (1)

  • Adverse Events

    3 months

Study Arms (2)

Intracameral levofloxacin

EXPERIMENTAL

0.5% unpreserved solution

Drug: Levofloxacin Ophthalmic

Intracameral moxifloxacin

EXPERIMENTAL

0.5% unpreserved solution

Drug: Moxifloxacin Ophthalmic

Interventions

Levofloxacin OphthalmicDRUG

0.1 ml of unpreserved 0.5% levofloxacin

Intracameral levofloxacin
Moxifloxacin OphthalmicDRUG

0.1 ml of unpreserved 0.5% moxifloxacin

Intracameral moxifloxacin

Eligibility Criteria

Age21 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eyes undergoing uncomplicated cataract surgery by phacoemulsification

You may not qualify if:

  • Corneal opacities, corneal dystrophies, glaucoma, uveitis, retinopathy, optic neuropathy, concomitant infection (blepharitis, hordeolum, or conjunctivitis) or uncontrolled systemic disease and intraoperative complications that may affect visual outcomes were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peregrine Eye and Laser Instittute

Makati City, MM, 1209, Philippines

Location

MeSH Terms

Conditions

Endophthalmitis

Condition Hierarchy (Ancestors)

Eye InfectionsInfectionsEye Diseases

Study Officials

  • Harvey S Uy, MD

    Peregrine Eye and Laser Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
unlabelled syringe containing interventional drug
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

May 21, 2020

First Posted

May 27, 2020

Study Start

January 2, 2018

Primary Completion

April 28, 2018

Study Completion

April 28, 2018

Last Updated

May 27, 2020

Record last verified: 2020-05

Locations

PH(1)