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

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 -

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.

Study Overview

• Status: Completed
• Conditions: Cataract Surgery
• Intervention / Treatment: Drug: DE-108; Drug: Levofloxacin 0.5%

• Study Type: Interventional
• Enrollment (Actual): 576
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Kyungpook, Korea, Republic of
    • Kyungpook National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Kim's Eye Hospital
  • Seoul, Korea, Republic of
    • Seoul Saint Marry's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DE-108; High concentration / Antibacterial Ophthalmic Solution	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.; Other Names: Levofloxacin
Active Comparator: Levofloxacin 0.5%; Low concentration / Antibacterial Ophthalmic Solution	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Santen Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2015
• Primary Completion (Actual): March 31, 2017
• Study Completion (Actual): March 31, 2017

Study Registration Dates

• First Submitted: October 7, 2015
• First Submitted That Met QC Criteria: October 9, 2015
• First Posted (Estimate): October 12, 2015

Study Record Updates

• Last Update Posted (Actual): October 12, 2017
• Last Update Submitted That Met QC Criteria: October 10, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Levofloxacin; Ofloxacin
• Other Study ID Numbers: DE-108