Cataract Surgery
Conditions
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.
Interventions
DRUGDE-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.
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.
Sponsors
Santen Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the percentage of positive bacteriological test results (from Day -3 to Day 0) | 3 days (Day -3 to Day0) |
Countries
South Korea
Outcome results
None listed