Overview

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

Status:
Completed
Trial end date:
2017-03-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Santen Pharmaceutical Co., Ltd.
Treatments:
Levofloxacin
Ofloxacin
Ophthalmic Solutions
Pharmaceutical Solutions
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