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

NCT01804361 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2015-07-22

No results posted yet for this 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.

Conditions

  • Dry Eye Syndromes

Interventions

DRUG

Haporine-S

1 or 2 drops twice a day at 12 hour interval for 12 weeks

DRUG

Restasis (cyclosporine 0.05%)

1 or 2 drops twice a day at 12 hour interval for 12 weeks

Sponsors & Collaborators

  • BTO Pharm. Co., Ltd.

    collaborator INDUSTRY

  • DH Bio Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hyo-Myung KIM, MD, PhD · Korea University Anam Hospital

  • Jong Suk SONG, MD, PhD · Korea University Guro Hospital

  • Hyung Keun LEE, MD, PhD · Yonsei University Gangnam Severance Hospital

  • Jong-Soo LEE, MD, PhD · Busan National University Hospital

  • Mee Kum KIM, MD, PhD · Seoul National University Hospital

  • Myoung-Joon KIM, MD, PhD · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01804361 on ClinicalTrials.gov