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Completed

NCT Number: NCT02573610

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

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.

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Key information

Conditions

Cataract Surgery

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kyungpook National University Hospital, Kyungpook, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DE-108

Drug

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.

Other names: Levofloxacin

Levofloxacin 0.5%

Drug

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.

Primary outcomes

  1. Change in the percentage of positive bacteriological test results (from Day -3 to Day 0)

    Time frame: 3 days (Day -3 to Day0)

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Sponsors and collaborators

Lead sponsor

Santen Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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 -

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 12, 2015
Registry last updated
Oct 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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