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

Cataract Surgery Clinical Trial

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 -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02573610
• Other study ID #: DE-108
• 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
• 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

Related Conditions & MeSH terms

• Cataract
• 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.
• 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)