Study of DE-108 Ophthalmic Solution in Patients Who Are Scheduled for Cataract Surgery
NCT ID: NCT02573610
Last Updated: 2017-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
576 participants
INTERVENTIONAL
2015-09-21
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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DE-108
High concentration / Antibacterial Ophthalmic Solution
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.
Levofloxacin 0.5%
Low concentration / Antibacterial Ophthalmic Solution
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
19 Years
ALL
No
Sponsors
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Santen Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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DE-108
Identifier Type: -
Identifier Source: org_study_id