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Dropless vs. Standard Drops Contralateral Eye Study

NCT02515045 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2018-02-23

Study results available
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Summary

To compare the use of an injectable compound containing an antibiotic and an anti-inflammatory at time of cataract surgery to standard of care that is the use 3 different topical medications to prevent inflammation and infection after routine cataract surgery.

Conditions

  • Cataract

Interventions

DRUG

TriMoxiVanc

triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.

DRUG

Moxifloxacin HCl 0.5%

Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.

DRUG

Ilevro

NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.

DRUG

Prednisolone acetate 1%

Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.

Sponsors & Collaborators

  • Science in Vision

    collaborator OTHER

  • Carolina Eyecare Physicians, LLC

    lead OTHER

Principal Investigators

  • Kerry D Solomon, MD · Carolina Eyecare Physicians, LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02515045 on ClinicalTrials.gov