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

• ClinicalTrials.gov Identifier: NCT02573610
• Recruitment Status: Completed
• First Posted: October 12, 2015
• Last Update Posted: October 12, 2017
• Sponsor: Santen Pharmaceutical Co., Ltd.
• Information provided by (Responsible Party): Santen Pharmaceutical Co., Ltd.

Tracking Information

• First Submitted Date: October 7, 2015
• First Posted Date: October 12, 2015
• Last Update Posted Date: October 12, 2017
• Actual Study Start Date: September 21, 2015
• Actual Primary Completion Date: March 31, 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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 -
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Cataract Surgery

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 10, 2017): 576
• Original Estimated Enrollment (submitted: October 9, 2015): 430
• Actual Study Completion Date: March 31, 2017
• Actual Primary Completion Date: March 31, 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT02573610
• Other Study ID Numbers: DE-108
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Santen Pharmaceutical Co., Ltd.
• Study Sponsor: Santen Pharmaceutical Co., Ltd.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Santen Pharmaceutical Co., Ltd.
• Verification Date: October 2017