Efficacy and Safety of HU007 Eye Drops in Patients With Dry Eye Syndrome

• Status: Completed
• Trial end date: 2018-07-12
• Target enrollment: 0
• Participant gender: All

Summary

A multicenter, Randomized, Double blind, Restasis®-controlled Non-inferiority, Moisview® Eye Drops-controlled Superiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients with Dry Eye Syndrome

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

Details

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

Criteria

Inclusion Criteria:

• age over 19

• Corneal staining score(Oxford grading) ≥ 2 or Schirmer test ≤ 10mm/5min (If Schirmer test = 0mm/5min, Nasal stimulation schirmer test ≥ 3mm/5min)

• Volunteer who went through menopause more than 1 years ago before screening or has surgical menopause or who has negative result of pregnancy test or use effective contraception

Exclusion Criteria:

• The patients with systemic or ocular disorders affected the test result

• Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status

• Being treated with systemic steroid

• Wearing contact lenses within 72 hr of screening visit

• Pregnancy or Breastfeeding