Back to resultsHU007 in Patients With Dry Eye Syndrome
Primary Purpose
Dry Eye Disease
Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HU007
Restasis
Moisview Eye drop
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Disease
Eligibility Criteria
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
Sites / Locations
- Gyeongsang National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
HU007
Restasis
Moisview
Arm Description
Cyclosporine 0.02%, trehalose 3% 1 drop b.i.d at 12hr interval for 12 weeks
Cyclosporine 0.05% 1 drop b.i.d at 12hr interval for 12 weeks
trehalose 3% 1 drop b.i.d at 12hr interval for 12 weeks
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05743764
Brief Title
HU007 in Patients With Dry Eye Syndrome
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Huons Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
328 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HU007
Arm Type
Experimental
Arm Description
Cyclosporine 0.02%, trehalose 3%
1 drop b.i.d at 12hr interval for 12 weeks
Arm Title
Restasis
Arm Type
Active Comparator
Arm Description
Cyclosporine 0.05%
1 drop b.i.d at 12hr interval for 12 weeks
Arm Title
Moisview
Arm Type
Active Comparator
Arm Description
trehalose 3%
1 drop b.i.d at 12hr interval for 12 weeks
Intervention Type
Drug
Intervention Name(s)
HU007
Intervention Description
cyclosporine 0.02%, trehalose 3%
Intervention Type
Drug
Intervention Name(s)
Restasis
Intervention Description
cyclosporine 0.05%
Intervention Type
Drug
Intervention Name(s)
Moisview Eye drop
Intervention Description
trehalose 3%
Primary Outcome Measure Information:
Title
change from Baseline in Corneal staining(Oxford grading) score
Description
change from Baseline in Corneal staining(Oxford grading) score
- Oxford grading:0(Absent) to 5(Severe)
Time Frame
Week12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dawon Park
Phone
+82-70-7492-5974
Email
dwpark@huons.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hyoju Pyo
Phone
+82-7492-5737
Email
hyoju@huosn.com
Facility Information:
Facility Name
Gyeongsang National University Hospital
City
Jinju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KIM
12. IPD Sharing Statement
Plan to Share IPD
No
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HU007 in Patients With Dry Eye Syndrome
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