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

Santen

Status and phase: Completed; Phase 3

Conditions: Cataract Surgery

Treatments: Drug: DE-108; Drug: Levofloxacin 0.5%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02573610

DE-108

Details and patient eligibility

About

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.

Enrollment: 576 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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576 participants in 2 patient groups

DE-108

Experimental group

Description:

High concentration / Antibacterial Ophthalmic Solution

Treatment:

Drug: DE-108

Levofloxacin 0.5%

Active Comparator group

Description:

Low concentration / Antibacterial Ophthalmic Solution

Treatment:

Drug: Levofloxacin 0.5%