Back to resultsStudy of DE-108 Ophthalmic Solution in Patients Who Are Scheduled for Cataract Surgery
Primary Purpose
Cataract Surgery
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DE-108
Levofloxacin 0.5%
Sponsored by
About this trial
This is an interventional prevention trial for Cataract Surgery
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
Sites / Locations
- Kyungpook National University Hospital
- Asan Medical Center
- Kim's eye Hospital
- Seoul National University Bundang Hospital
- Seoul Saint Marry's Hospital
- Severance Hospital, Yonsei University Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DE-108
Levofloxacin 0.5%
Arm Description
High concentration / Antibacterial Ophthalmic Solution
Low concentration / Antibacterial Ophthalmic Solution
Outcomes
Primary Outcome Measures
Change in the percentage of positive bacteriological test results (from Day -3 to Day 0)
Secondary Outcome Measures
Full Information
NCT ID
NCT02573610
First Posted
October 7, 2015
Last Updated
October 10, 2017
Sponsor
Santen Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02573610
Brief Title
Study of DE-108 Ophthalmic Solution in Patients Who Are Scheduled for Cataract Surgery
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 -
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 21, 2015 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
March 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
576 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DE-108
Arm Type
Experimental
Arm Description
High concentration / Antibacterial Ophthalmic Solution
Arm Title
Levofloxacin 0.5%
Arm Type
Active Comparator
Arm Description
Low concentration / Antibacterial Ophthalmic Solution
Intervention Type
Drug
Intervention Name(s)
DE-108
Other Intervention Name(s)
Levofloxacin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Levofloxacin 0.5%
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the percentage of positive bacteriological test results (from Day -3 to Day 0)
Time Frame
3 days (Day -3 to Day0)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Kyungpook National University Hospital
City
Kyungpook
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Kim's eye Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Saint Marry's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Study of DE-108 Ophthalmic Solution in Patients Who Are Scheduled for Cataract Surgery
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