Efficacy and Safety of HE10 for Dry Eye Syndrome

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huons Co., Ltd.; Huons Co.,Ltd.
• Treatments: Cyclosporine; Cyclosporins

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