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

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Drug: Haporine-S; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 602-739
    • Busan National University Hospital
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 152-703
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 136-705
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 135-720
    • Yonsei University Gangnam Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal staining	Corneal fluorescein staining will be assessed at 0 day(baseline), 4 weeks and 12 weeks.	up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Surface Disease Index(OSID)	Ocular Surface Disease Index(OSID) will be assessed at 0 day, 4 weeks and 12 weeks.	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.	0 day, 4 weeks and 12 weeks
Schirmer score	Schirmer score will be assessed at 0 day(baseline), 4 weeks and 12 weeks.	0 day, 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.	0 day, 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.	0 day, 4 weeks and 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Adverse Event will be assessed for the whole study period(1 year).	1 year
Serious Adverse Events	Serious Adverse Event will be assessed for the whole study period(1 year).	1 year

Collaborators and Investigators

• Sponsor: DH Bio Co., Ltd.
• Collaborators: 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: Myoung-Joon KIM, MD, PhD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): February 1, 2014
• Study Completion (ACTUAL): February 1, 2014

Study Registration Dates

• First Submitted: February 27, 2013
• First Submitted That Met QC Criteria: March 4, 2013
• First Posted (ESTIMATE): March 5, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): July 22, 2015
• Last Update Submitted That Met QC Criteria: July 20, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Dry Eye Syndromes
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Calcineurin Inhibitors; Cyclosporine; Cyclosporins
• Other Study ID Numbers: UMT-2012-DH-HS-01; 1360-8040-3073-4190 (OTHER: Korea Food and Drug Administration)