Efficacy and Safety Study of Haporine-S for Treatment of Moderate to Severe Dry Eye Syndromes

Last updated: July 20, 2015
Sponsor: DH Bio Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Dry Eye Disease

Sjogren's Syndrome

Dry Eyes

Treatment

N/A

Clinical Study ID

NCT01804361
UMT-2012-DH-HS-01
1360-8040-3073-4190
  • Ages > 20
  • All Genders

Study Summary

The purpose of this study is to determine efficacy and safety of Haporine-S eye drop for the patients with moderate to severe dry eye disease in a multicenter phase III clinical trial.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female, age 20 or over

  • Patients with moderate to severe dry eye(DEWS Level II or over)

  • Be informed of the nature of the study and will give written informed consent

Exclusion

Exclusion Criteria:

  • Being treated with steroidal eye drop or non-steroidal anti-inflammatory eye drop fordry eye

  • Being treated with systemic steroid or immunosuppressive

  • History of eyeball surgical operation within 6 months

  • Wearing contact lenses during participation of the study

  • Pregnancy or breastfeeding

  • Use of cyclosporine eye drop within 2 weeks

  • Intraocular pressure(IOP)> 25 mmHg

  • History of punctal occlusion within 1 month or during participation of the study

  • Hypersensitivity to the investigational products or be suspicious to them

  • Patients whom the investigator considers inappropriate to participate in the study

Study Design

Total Participants: 90
Study Start date:
March 01, 2013
Estimated Completion Date:
February 28, 2014

Study Description

This study is to compare the efficacy and the safety of topical Haposine-S and Restasis® eye drop 0.05% for the patients with moderate to severe dry eye disease in a multicenter, investigator(assessor) blind, parallel design, non-inferiority phase III trial.

Primary outcome is the change of corneal staining score(Oxford scheme) at 12 weeks from baseline.

Connect with a study center

  • Busan National University Hospital

    Busan, 602-739
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 138-736
    Korea, Republic of

    Site Not Available

  • Korea University Anam Hospital

    Seoul, 136-705
    Korea, Republic of

    Site Not Available

  • Korea University Guro Hospital

    Seoul, 152-703
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 110-744
    Korea, Republic of

    Site Not Available

  • Yonsei University Gangnam Severance Hospital

    Seoul, 135-720
    Korea, Republic of

    Site Not Available

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