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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02573610
Other study ID # DE-108
Secondary ID
Status Completed
Phase Phase 3
First received October 7, 2015
Last updated October 10, 2017
Start date September 21, 2015
Est. completion date March 31, 2017

Study information

Verified date October 2017
Source Santen Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 576
Est. completion date March 31, 2017
Est. primary completion date March 31, 2017
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


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.
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.

Locations

Country Name City State
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

Sponsors (1)

Lead Sponsor Collaborator
Santen Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the percentage of positive bacteriological test results (from Day -3 to Day 0) 3 days (Day -3 to Day0)
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