Trials Sponsors Conditions Drugs Pricing

Conditions

Cataract Surgery

Outcome Measures

Primary Outcomes (1)

Change in the percentage of positive bacteriological test results (from Day -3 to Day 0)
3 days (Day -3 to Day0)

Study Arms (2)

DE-108

EXPERIMENTAL

High concentration / Antibacterial Ophthalmic Solution

Drug: DE-108

Levofloxacin 0.5%

ACTIVE COMPARATOR

Low concentration / Antibacterial Ophthalmic Solution

Drug: Levofloxacin 0.5%

Interventions

DE-108Drug

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.

Also known as: Levofloxacin

DE-108

Levofloxacin 0.5%Drug

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.

Eligibility Criteria

Age19 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Those who are scheduled for cataract surgery

You may not qualify if:

Sponsors & Collaborators

Santen Pharmaceutical Co., Ltd.
Industrylead

Study Sites (6)

Kyungpook National University Hospital

Kyungpook, South Korea

Asan Medical Center

Seoul, South Korea

Kim's eye Hospital

Seoul, South Korea

Seoul National University Bundang Hospital

Seoul, South Korea

Seoul Saint Marry's Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

MeSH Terms

Interventions

Levofloxacin

Intervention Hierarchy (Ancestors)

OfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Enrollment

576 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 7, 2015

First Posted

October 12, 2015

Study Start

September 21, 2015

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

DE-108

Levofloxacin 0.5%

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

DE-108

Levofloxacin 0.5%

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Source record

Locations