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 -
1 other identifier
interventional
576
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2015
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 21, 2015
CompletedFirst Submitted
Initial submission to the registry
October 7, 2015
CompletedFirst Posted
Study publicly available on registry
October 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2017
CompletedOctober 12, 2017
October 1, 2017
1.5 years
October 7, 2015
October 10, 2017
Conditions
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
EXPERIMENTALHigh concentration / Antibacterial Ophthalmic Solution
Levofloxacin 0.5%
ACTIVE COMPARATORLow concentration / Antibacterial Ophthalmic Solution
Interventions
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.
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
You may qualify if:
- Those who are scheduled for cataract surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
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
Intervention Hierarchy (Ancestors)
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
Primary Completion
March 31, 2017
Study Completion
March 31, 2017
Last Updated
October 12, 2017
Record last verified: 2017-10