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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01804361

Enrollment

Registered

2013-03-05

Start date

2013-03-31

Completion date

2014-02-28

Last updated

2015-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes

Keywords

Dry Eye Syndromes

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.

Interventions

DRUGHaporine-S

1 or 2 drops twice a day at 12 hour interval for 12 weeks

DRUGRestasis (cyclosporine 0.05%)

1 or 2 drops twice a day at 12 hour interval for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026