Efficacy and Safety of HE10 for Dry Eye Syndrome

Huons

Status and phase

Completed

Phase 3

Conditions

Dry Eye Syndrome

Treatments

Drug: HE 10

Drug: Restasis

Study type

Interventional

Funder types

Industry

Identifiers

NCT02492412

Huons

Details and patient eligibility

About

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.

Full 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.

Enrollment

101 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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