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

• Sponsor: DH Bio Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01804361
• Collaborator: BTO Pharm. Co., Ltd. (Industry)
• Enrollment: 90
• Locations: 6
• Arms: 2
• Duration (Months): 11.1
• Patients Per Site: 15
• Patients Per Site Per Month: 1.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes	Drug: Haporine-S; Drug: Restasis (cyclosporine 0.05%)	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (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
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Feb 1, 2014
• Actual Study Completion Date: Feb 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Corneal staining [up to 12 weeks]

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

Secondary Outcome Measures

1. Ocular Surface Disease Index(OSID) [0 day, 4 weeks and 12 weeks]

   Ocular Surface Disease Index(OSID) will be assessed at 0 day, 4 weeks and 12 weeks.

2. Tear Breakup Time(TBUT) [0 day, 4 weeks and 12 weeks]

   Tear Breakup Time(TBUT) will be assessed at 0 day(baseline), 4 weeks and 12 weeks.

3. Schirmer score [0 day, 4 weeks and 12 weeks]

   Schirmer score will be assessed at 0 day(baseline), 4 weeks and 12 weeks.

4. Drug compliance [0 day, 4 weeks and 12 weeks]

   Drug compliance(conjunctival hyperemia and burning etc) will be assessed at 0 day(baseline), 4 weeks and 12 weeks.

5. DEWS(Dry Eye WorkShop) level [0 day, 4 weeks and 12 weeks]

   Level on dry eye severity grading scheme of DEWS will be assessed at 0 day(baseline), 4 weeks and 12 weeks.

Other Outcome Measures

1. Adverse Events [1 year]

   Adverse Event will be assessed for the whole study period(1 year).

2. Serious Adverse Events [1 year]

   Serious Adverse Event will be assessed for the whole study period(1 year).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Busan National University Hospital	Busan		Korea, Republic of	602-739
2	Seoul National University Hospital	Seoul		Korea, Republic of	110-744
3	Yonsei University Gangnam Severance Hospital	Seoul		Korea, Republic of	135-720
4	Korea University Anam Hospital	Seoul		Korea, Republic of	136-705
5	Asan Medical Center	Seoul		Korea, Republic of	138-736
6	Korea University Guro Hospital	Seoul		Korea, Republic of	152-703

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: DH Bio Co., Ltd.
• ClinicalTrials.gov Identifier: NCT01804361
• Other Study ID Numbers: UMT-2012-DH-HS-01; 1360-8040-3073-4190
• First Posted: Mar 5, 2013
• Last Update Posted: Jul 22, 2015
• Last Verified: Jul 1, 2015

• Keywords provided by DH Bio Co., Ltd.: Dry Eye Syndromes
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome; Cyclosporine; Cyclosporins

Study Results

No Results Posted as of Jul 22, 2015