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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02573610
Recruitment Status : Completed
First Posted : October 12, 2015
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Santen Pharmaceutical Co., Ltd.

Tracking Information
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
 (submitted: October 9, 2015)		 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
Condition  ICMJE Cataract Surgery
Intervention  ICMJE
  • 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 Name: Levofloxacin
  • 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.
Study Arms  ICMJE
  • Experimental: DE-108
    High concentration / Antibacterial Ophthalmic Solution
    Intervention: Drug: DE-108
  • Active Comparator: Levofloxacin 0.5%
    Low concentration / Antibacterial Ophthalmic Solution
    Intervention: Drug: Levofloxacin 0.5%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2017)		 576
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2015)		 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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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