Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

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.

Condition or disease Intervention/treatment Phase
Cataract Surgery Drug: DE-108 Drug: Levofloxacin 0.5% Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 576 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 -
Actual Study Start Date : September 21, 2015
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: DE-108
High concentration / Antibacterial Ophthalmic Solution
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

Active Comparator: Levofloxacin 0.5%
Low concentration / Antibacterial Ophthalmic Solution
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.




Primary Outcome Measures :
  1. Change in the percentage of positive bacteriological test results (from Day -3 to Day 0) [ Time Frame: 3 days (Day -3 to Day0) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573610


Locations
Layout table for location information
Korea, Republic of
Kyungpook National University Hospital
Kyungpook, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Kim's eye Hospital
Seoul, Korea, Republic of
Seoul National University Bundang Hospital
Seoul, Korea, Republic of
Seoul Saint Marry's Hospital
Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of
Sponsors and Collaborators
Santen Pharmaceutical Co., Ltd.
Layout table for additonal information
Responsible Party: Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02573610    
Other Study ID Numbers: DE-108
First Posted: October 12, 2015    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Cataract
Lens Diseases
Eye Diseases
Levofloxacin
Ofloxacin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors