Efficacy and Safety of HE10 for Dry Eye Syndrome

NCT ID: NCT02492412

Last Updated: 2015-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-09-30

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of HE10 eye drop for the patients with moderate to severe dry eye syndrome.

Detailed Description

This study is to compare the efficacy and safety of HE10 and Restasis for patients with moderate to severe dry eye syndrome in multi-center, double-blind, randomized, active comparator-controlled, parallel design, non-inferiority Phase III clinical trial.

Conditions

Dry Eye Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HE10

Drug: HE10 1\~2 drops b.i.d at 12 hour interval for 12 weeks

Group Type: EXPERIMENTAL

HE 10

Intervention Type: DRUG

Restasis

Drug: Restasis(Cyclosporine 0.05%) 1\~2 drops b.i.d at 12 hour interval for 12 weeks

Group Type: ACTIVE_COMPARATOR

Restasis

Intervention Type: DRUG

Interventions

HE 10

Intervention Type: DRUG

Restasis

Intervention Type: DRUG

Other Intervention Names

0.05% cyclosporine

Eligibility Criteria

Inclusion Criteria

• Corneal staining score of ≥2(Oxford grade)
• Schirmer test score (without anesthesia) < 10 mm/5 min in either eye
• Tear break-up time is 10 seconds or less
• Screening both eyes, the corrected visual acuity is 0.2 or more

Exclusion Criteria

• Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
• The patients with systemic or ocular disorders affected the test result
• Being treated with systemic steroid
• History of eyeball surgical operation within 3 months of screening visit
• Wearing contact lenses within 2 weeks of screening visit
• Be a use or used punctual plug within 1 month of screening vist
• Use of cyclosporine eye drop within 3 weeks
• Pregnancy or Breastfeeding
• Intraocular pressure > 25 mmHg
• Abnormal eyelid function : Disorders of the eyelids or eyelashes

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huons Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Huons

Identifier Type: -

Identifier Source: org_study_id