Dry Eye Disease Clinical Trial
Official title:
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
Verified date | February 2023 |
Source | Huons Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 328 |
Est. completion date | February 14, 2024 |
Est. primary completion date | February 14, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria - Age over 19 - Corneal staining score(Oxford grading) = 2 and Schirmer test = 10mm/5min (If Schirmer test = 0mm/5min, Nasal stimulation schirmer test = 3mm/5min) and TBUT test =10 in at least one of both eyes - Volunteer who have had more than one symptom of dry eye disease for at least 3 month before screening visit. Exclusion Criteria: - The patients with clinically significant ocular disorders affected the test result - Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status - SBP =140mmHg or DBP = 90mmHg or HbA1c>9% - Wearing contact lenses within 72 hr of screening visit - Pregnancy or Breastfeeding |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Gyeongsang National University Hospital | Jinju |
Lead Sponsor | Collaborator |
---|---|
Huons Co., Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change from Baseline in Corneal staining(Oxford grading) score | change from Baseline in Corneal staining(Oxford grading) score
- Oxford grading:0(Absent) to 5(Severe) |
Week12 |
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