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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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 2 patient groups

Haporine-S
Experimental group
Description:
Moderate to severe dry patients administered with with Haporine-S
Treatment:
Drug: Haporine-S
Restasis, Cyclosporine 0.05%
Active Comparator group
Description:
Moderate to severe dry eye patients with Restasis(cyclosporine 0.05%)
Treatment:
Drug: Restasis (cyclosporine 0.05%)

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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