Efficacy and Safety of HU007 Eye Drops in Patients With Dry Eye Syndrome
Study Details
Study Description
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 Patients with Dry Eye Syndrome
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: HU007 Cyclosporine 0.02%, trehalose 3% 1 drop b.i.d at 12hr interval for 12 weeks |
Drug: HU007
cyclosporine 0.02%, trehalose 3%
|
Active Comparator: Restasis Cyclosporine 0.05% 1 drop b.i.d at 12hr interval for 12 weeks |
Drug: Restasis
cyclosporine 0.05%
|
Active Comparator: Moisview trehalose 3% 1 drop b.i.d at 12hr interval for 12 weeks |
Drug: Moisview
trehalose 3%
|
Outcome Measures
Primary Outcome Measures
- change from Baseline in Corneal staining(Oxford grading) score [Week 12]
Secondary Outcome Measures
- change from Baseline in Corneal staining(Oxford grading) score [Week 4,8]
- change from Baseline of Conjunctival staining(Oxford grading) score [Week 4,8,12]
- change from Baseline of Strip meniscometry assessment [Week 4,8,12]
- change from Baseline of Tear film break-up time [Week 4,8,12]
- change from Baseline of Standard patient evaluation of eye dryness questionnaire [Week 4,8,12]
- arrival time of 100% clearence in Corneal staining test [Week 0-12]
- The number of total rescue drug usage [Week 0-12]
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Seoul ST.Mary's Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Huons Co., Ltd.
Investigators
- Study Director: Namsick Kim, Huons Co., Ltd.
- Principal Investigator: Choun-Ki Joo, Seoul St. Mary's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HU-007_P3