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

Sponsor
Santen Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02573610
Collaborator
(none)
576
Enrollment
6
Locations
2
Arms
18.3
Actual Duration (Months)
96
Patients Per Site
5.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
576 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
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 -
Actual Study Start Date :
Sep 21, 2015
Actual Primary Completion Date :
Mar 31, 2017
Actual Study Completion Date :
Mar 31, 2017

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kyungpook National University Hospital Kyungpook Korea, Republic of
    2 Asan Medical Center Seoul Korea, Republic of
    3 Kim's eye Hospital Seoul Korea, Republic of
    4 Seoul National University Bundang Hospital Seoul Korea, Republic of
    5 Seoul Saint Marry's Hospital Seoul Korea, Republic of
    6 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of

    Sponsors and Collaborators

    • Santen Pharmaceutical Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Santen Pharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT02573610
    Other Study ID Numbers:
    • DE-108
    First Posted:
    Oct 12, 2015
    Last Update Posted:
    Oct 12, 2017
    Last Verified:
    Oct 1, 2017
    Additional relevant MeSH terms:
    Cataract
    Levofloxacin
    Ofloxacin

    Study Results

    No Results Posted as of Oct 12, 2017