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

Dry Eye Syndromes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01804361
• Other study ID #: UMT-2012-DH-HS-01
• Secondary ID: 1360-8040-3073-4
• Status: Completed
• Phase: Phase 3
• First received: February 27, 2013
• Last updated: July 20, 2015
• Start date: March 2013
• Est. completion date: February 2014

Study information

• Verified date: July 2015
• Source: DH Bio Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Haporine-S
1 or 2 drops twice a day at 12 hour interval for 12 weeks
• Restasis (cyclosporine 0.05%)
1 or 2 drops twice a day at 12 hour interval for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Busan National University Hospital	Busan
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Yonsei University Gangnam Severance Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
DH Bio Co., Ltd.	BTO Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events	Adverse Event will be assessed for the whole study period(1 year).	1 year	Yes
Other	Serious Adverse Events	Serious Adverse Event will be assessed for the whole study period(1 year).	1 year	Yes
Primary	Corneal staining	Corneal fluorescein staining will be assessed at 0 day(baseline), 4 weeks and 12 weeks.	up to 12 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	Schirmer score	Schirmer score will be assessed at 0 day(baseline), 4 weeks and 12 weeks.	0 day, 4 weeks and 12 weeks	No
Secondary	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	No
Secondary	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	No