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

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Status and phase

Completed

Phase 3

Conditions

Dry Eye Syndromes

Treatments

Drug: Restasis (cyclosporine 0.05%)

Drug: Haporine-S

Study type

Interventional

Funder types

Industry

Identifiers

NCT01804361

1360-8040-3073-4190 (Other Identifier)

UMT-2012-DH-HS-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

20+ years old

Volunteers

No 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