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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by DH Bio Co., Ltd.
Sponsor:
Collaborator:
BTO Pharm Co Ltd
Information provided by (Responsible Party):
DH Bio Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01804361
First received: February 27, 2013
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Dry Eye Syndromes
Drug: Haporine-S
Drug: Restasis (cyclosporine 0.05%)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by DH Bio Co., Ltd.:

Primary Outcome Measures:
  • Corneal staining [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    Corneal fluorescein staining will be assessed at 0 day(baseline), 4 weeks and 12 weeks.


Secondary Outcome Measures:
  • Ocular Surface Disease Index(OSID) [ Time Frame: 0 day, 4 weeks and 12 weeks ] [ Designated as safety issue: No ]
    Ocular Surface Disease Index(OSID) will be assessed at 0 day, 4 weeks and 12 weeks.

  • Tear Breakup Time(TBUT) [ Time Frame: 0 day, 4 weeks and 12 weeks ] [ Designated as safety issue: No ]
    Tear Breakup Time(TBUT) will be assessed at 0 day(baseline), 4 weeks and 12 weeks.

  • Schirmer score [ Time Frame: 0 day, 4 weeks and 12 weeks ] [ Designated as safety issue: No ]
    Schirmer score will be assessed at 0 day(baseline), 4 weeks and 12 weeks.

  • Drug compliance [ Time Frame: 0 day, 4 weeks and 12 weeks ] [ Designated as safety issue: No ]
    Drug compliance(conjunctival hyperemia and burning etc) will be assessed at 0 day(baseline), 4 weeks and 12 weeks.

  • DEWS(Dry Eye WorkShop) level [ Time Frame: 0 day, 4 weeks and 12 weeks ] [ Designated as safety issue: No ]
    Level on dry eye severity grading scheme of DEWS will be assessed at 0 day(baseline), 4 weeks and 12 weeks.


Other Outcome Measures:
  • Adverse Events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Adverse Event will be assessed for the whole study period(1 year).

  • Serious Adverse Events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Serious Adverse Event will be assessed for the whole study period(1 year).


Estimated Enrollment: 90
Study Start Date: March 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Haporine-S
Moderate to severe dry patients administered with with Haporine-S
Drug: Haporine-S
1 or 2 drops twice a day at 12 hour interval for 12 weeks
Other Name: Haporine-S
Active Comparator: Restasis, Cyclosporine 0.05%
Moderate to severe dry eye patients with Restasis(cyclosporine 0.05%)
Drug: Restasis (cyclosporine 0.05%)
1 or 2 drops twice a day at 12 hour interval for 12 weeks
Other Name: Restasis (cyclosporine 0.05%)

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01804361

Contacts
Contact: Hyo-Myung Kim, MD, PhD +82-2-920-5776

Locations
Korea, Republic of
Busan National University Hospital Recruiting
Busan, Korea, Republic of, 602-739
Contact: Jong-Soo LEE, MD, PhD         
Principal Investigator: Jong-Soo LEE, MD, PhD         
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of, 136-705
Contact: Hyo-Myung KIM, MD, PhD    +82-2-920-5776      
Principal Investigator: Hyo-Myung KIM, MD, PhD         
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of, 152-703
Contact: Jong Suk SONG, MD, PhD         
Principal Investigator: Jong Suk SONG, MD, PhD         
Yonsei University Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of, 135-720
Contact: Hyung Keun LEE, MD, PhD         
Principal Investigator: Hyung Keun LEE, MD, PhD         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Mee Kum KIM, MD, PhD         
Principal Investigator: Mee Kum KIM, MD, PhD         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Myoung-Joon KIM, MD, PhD         
Principal Investigator: Myoung-Joon KIM, MD, PhD         
Sponsors and Collaborators
DH Bio Co., Ltd.
BTO Pharm Co Ltd
Investigators
Principal Investigator: Hyo-Myung KIM, MD, PhD Korea University Anam Hospital
Principal Investigator: Jong Suk SONG, MD, PhD Korea University Guro Hospital
Principal Investigator: Hyung Keun LEE, MD, PhD Yonsei University Gangnam Severance Hospital
Principal Investigator: Jong-Soo LEE, MD, PhD Busan National University Hospital
Principal Investigator: Mee Kum KIM, MD, PhD Seoul National University Hospital
Principal Investigator: Myoung-Joon KIM, MD, PhD Asan Medical Center
  More Information

No publications provided

Responsible Party: DH Bio Co., Ltd.
ClinicalTrials.gov Identifier: NCT01804361     History of Changes
Other Study ID Numbers: UMT-2012-DH-HS-01, 1360-8040-3073-4190
Study First Received: February 27, 2013
Last Updated: September 30, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by DH Bio Co., Ltd.:
Dry Eye Syndromes

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 22, 2014