Status:
COMPLETED
Efficacy and Safety of HU007 Eye Drops in Patients With Dry Eye Syndrome
Lead Sponsor:
Huons Co., Ltd.
Conditions:
Dry Eye Syndrome
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief 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 Pat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2018
Estimated Enrollment :
209 Patients enrolled
Trial Details
Trial ID
NCT03461575
Start Date
January 22 2018
End Date
July 12 2018
Last Update
May 8 2020
Active Locations (1)
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1
Seoul ST.Mary's Hospital
Seoul, South Korea