NCT02573610

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

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 -

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 576 (actual)
• Sponsor: Santen Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cataract Surgery

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2015-09-21
• Primary completion: 2017-03-31
• Completion: 2017-03-31
• First posted: 2015-10-12
• Last updated: 2017-10-12

Locations

6 sites across 1 country: South Korea