A Randomized, Double-masked, Parallel Group Study of DE-108 Ophthalmic Solution in Patients Who Are Scheduled for Cataract Surgery (Levofloxacin 0.5% Ophthalmic Solution as a Comparator) - Phase III, Confirmatory Study of Perioperative Bacteria Eradication -

Santen Pharmaceutical Co., Ltd.6 sites in 1 country576 target enrollmentSeptember 21, 2015

ConditionsCataract Surgery

InterventionsDE-108 Levofloxacin 0.5%

DrugsDE-108 Levofloxacin 0.5%

Overview

Phase: Phase 3
Intervention: DE-108
Conditions: Cataract Surgery
Sponsor: Santen Pharmaceutical Co., Ltd.
Enrollment: 576
Locations: 6
Primary Endpoint: Change in the percentage of positive bacteriological test results (from Day -3 to Day 0)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 21, 2015

End Date

March 31, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Santen Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Those who are scheduled for cataract surgery

Exclusion Criteria

•Those who with suspected ocular infections based on clinical findings in the study eye.
•Those who have any eye disease other than cataract which requires treatment in the target eye.
•Those who have a history of allergy to the drugs to be used during the clinical study (such as fluoroquinolones, topical anesthetics and povidon iodine)
•Those who need to wear contact lenses during the study period