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

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Haporine-S
Restasis (cyclosporine 0.05%)
Sponsored by
DH Bio Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes focused on measuring Dry Eye Syndromes

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Criteria:

  • 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
  • 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

Sites / Locations

  • Busan National University Hospital
  • Seoul National University Hospital
  • Yonsei University Gangnam Severance Hospital
  • Korea University Anam Hospital
  • Asan Medical Center
  • Korea University Guro Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Haporine-S

Restasis, Cyclosporine 0.05%

Arm Description

Moderate to severe dry patients administered with with Haporine-S

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

Outcomes

Primary Outcome Measures

Corneal staining
Corneal fluorescein staining will be assessed at 0 day(baseline), 4 weeks and 12 weeks.

Secondary Outcome Measures

Ocular Surface Disease Index(OSID)
Ocular Surface Disease Index(OSID) will be assessed at 0 day, 4 weeks and 12 weeks.
Tear Breakup Time(TBUT)
Tear Breakup Time(TBUT) will be assessed at 0 day(baseline), 4 weeks and 12 weeks.
Schirmer score
Schirmer score will be assessed at 0 day(baseline), 4 weeks and 12 weeks.
Drug compliance
Drug compliance(conjunctival hyperemia and burning etc) will be assessed at 0 day(baseline), 4 weeks and 12 weeks.
DEWS(Dry Eye WorkShop) level
Level on dry eye severity grading scheme of DEWS will be assessed at 0 day(baseline), 4 weeks and 12 weeks.

Full Information

First Posted
February 27, 2013
Last Updated
July 20, 2015
Sponsor
DH Bio Co., Ltd.
Collaborators
BTO Pharm. Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01804361
Brief Title
Efficacy and Safety Study of Haporine-S for Treatment of Moderate to Severe Dry Eye Syndromes
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DH Bio Co., Ltd.
Collaborators
BTO Pharm. Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
Keywords
Dry Eye Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Haporine-S
Arm Type
Experimental
Arm Description
Moderate to severe dry patients administered with with Haporine-S
Arm Title
Restasis, Cyclosporine 0.05%
Arm Type
Active Comparator
Arm Description
Moderate to severe dry eye patients with Restasis(cyclosporine 0.05%)
Intervention Type
Drug
Intervention Name(s)
Haporine-S
Intervention Description
1 or 2 drops twice a day at 12 hour interval for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Restasis (cyclosporine 0.05%)
Intervention Description
1 or 2 drops twice a day at 12 hour interval for 12 weeks
Primary Outcome Measure Information:
Title
Corneal staining
Description
Corneal fluorescein staining will be assessed at 0 day(baseline), 4 weeks and 12 weeks.
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Ocular Surface Disease Index(OSID)
Description
Ocular Surface Disease Index(OSID) will be assessed at 0 day, 4 weeks and 12 weeks.
Time Frame
0 day, 4 weeks and 12 weeks
Title
Tear Breakup Time(TBUT)
Description
Tear Breakup Time(TBUT) will be assessed at 0 day(baseline), 4 weeks and 12 weeks.
Time Frame
0 day, 4 weeks and 12 weeks
Title
Schirmer score
Description
Schirmer score will be assessed at 0 day(baseline), 4 weeks and 12 weeks.
Time Frame
0 day, 4 weeks and 12 weeks
Title
Drug compliance
Description
Drug compliance(conjunctival hyperemia and burning etc) will be assessed at 0 day(baseline), 4 weeks and 12 weeks.
Time Frame
0 day, 4 weeks and 12 weeks
Title
DEWS(Dry Eye WorkShop) level
Description
Level on dry eye severity grading scheme of DEWS will be assessed at 0 day(baseline), 4 weeks and 12 weeks.
Time Frame
0 day, 4 weeks and 12 weeks
Other Pre-specified Outcome Measures:
Title
Adverse Events
Description
Adverse Event will be assessed for the whole study period(1 year).
Time Frame
1 year
Title
Serious Adverse Events
Description
Serious Adverse Event will be assessed for the whole study period(1 year).
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyo-Myung KIM, MD, PhD
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jong Suk SONG, MD, PhD
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hyung Keun LEE, MD, PhD
Organizational Affiliation
Yonsei University Gangnam Severance Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jong-Soo LEE, MD, PhD
Organizational Affiliation
Busan National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mee Kum KIM, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Myoung-Joon KIM, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Busan National University Hospital
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Yonsei University Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of

12. IPD Sharing Statement

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

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