Efficacy and Safety Study of HU00701/HU007 Eye Drops in Patients With Dry Eye Syndrome

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A multicenter, Placebo controlled, Restasis® referenced, Randomized, Double blind, Phase II Study to Evaluate the Efficacy and Safety of HU00701/HU007 Eye Drops in Adult Patients with Dry Eye Syndrome

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

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

• Volunteer who has negative result of pregnancy test or use effective contraception

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

• Wearing contact lenses within 3 days of screening visit

• Pregnancy or Breastfeeding