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Study of DE-108 Ophthalmic Solution in Patients Who Are Scheduled for Cataract Surgery

NCT02573610 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 576

Last updated 2017-10-12

No results posted yet for this study

Summary

The purpose of this study is to evaluate superior efficacy of DE-108 ophthalmic solution to that of Levofloxacin 0.5% ophthalmic solution as well as safety of the former used for perioperative bacteria eradication in patients who are scheduled for cataract surgery.

Conditions

  • Cataract Surgery

Interventions

DRUG

DE-108

Subjects will be assigned to receive DE-108 ophthalmic solution to be administrated one drop a time 3 times daily for 3 days prior and for 14 days following cataract surgery.

DRUG

Levofloxacin 0.5%

Subjects will be assigned to receive Levofloxacin 0.5% ophthalmic solution to be administrated one drop a time 3 times daily for 3 days prior and for 14 days following cataract surgery.

Sponsors & Collaborators

  • Santen Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-21
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • South Korea

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 NCT02573610 on ClinicalTrials.gov