Study of DE-108 Ophthalmic Solution in Patients Who Are Scheduled for Cataract Surgery
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ClinicalTrials.gov Identifier: NCT02573610 |
Recruitment Status :
Completed
First Posted : October 12, 2015
Last Update Posted : October 12, 2017
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Sponsor:
Santen Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Santen Pharmaceutical Co., Ltd.
Tracking Information | |||
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First Submitted Date ICMJE | October 7, 2015 | ||
First Posted Date ICMJE | October 12, 2015 | ||
Last Update Posted Date | October 12, 2017 | ||
Actual Study Start Date ICMJE | September 21, 2015 | ||
Actual Primary Completion Date | March 31, 2017 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Change in the percentage of positive bacteriological test results (from Day -3 to Day 0) [ Time Frame: 3 days (Day -3 to Day0) ] | ||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | |||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Study of DE-108 Ophthalmic Solution in Patients Who Are Scheduled for Cataract Surgery | ||
Official Title ICMJE | 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 - | ||
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. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE | Cataract Surgery | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
576 | ||
Original Estimated Enrollment ICMJE |
430 | ||
Actual Study Completion Date ICMJE | March 31, 2017 | ||
Actual Primary Completion Date | March 31, 2017 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 19 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Korea, Republic of | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT02573610 | ||
Other Study ID Numbers ICMJE | DE-108 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Santen Pharmaceutical Co., Ltd. | ||
Study Sponsor ICMJE | Santen Pharmaceutical Co., Ltd. | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Santen Pharmaceutical Co., Ltd. | ||
Verification Date | October 2017 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |