Completed

Efficacy and Safety Study of Haporine-S in Subjects With Moderate to Severe Dry Eye, A Multicenter, Investigator(Assessor)Blind, Parallel Design, Non-inferiority Phase III Trial

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Haporine-S

+ Restasis (cyclosporine 0.05%)

Drug
Who is being recruted

Eye Diseases

+ Lacrimal Apparatus Diseases

+ Dry Eye Syndromes

Over 20 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorDH Bio Co., Ltd.
Last updated: July 22, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01804361
Principal SponsorDH Bio Co., Ltd.
Last updated: July 22, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

90 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesLacrimal Apparatus DiseasesDry Eye Syndromes

Criteria

3 inclusion criteria required to participate
Be informed of the nature of the study and will give written informed consent
Male or female, age 20 or over
Patients with moderate to severe dry eye(DEWS Level II or over)
10 exclusion criteria prevent from participating
Being treated with steroidal eye drop or non-steroidal anti-inflammatory eye drop for dry eye
Being treated with systemic steroid or immunosuppressive
History of eyeball surgical operation within 6 months
History of punctal occlusion within 1 month or during participation of the study
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Moderate to severe dry patients administered with with Haporine-S

Group II

Active Comparator
Moderate to severe dry eye patients with Restasis(cyclosporine 0.05%)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Busan National University Hospital

Busan, South KoreaOpen Busan National University Hospital in Google Maps

Seoul National University Hospital

Seoul, South Korea

Yonsei University Gangnam Severance Hospital

Seoul, South Korea

Korea University Anam Hospital

Seoul, South Korea
Completed6 Study Centers