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

Primary Purpose

Dry Eye Syndrome

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HU00701
HU007
Restasis
Placebo
Sponsored by
Huons Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndrome

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Huons

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

HU00701

HU007

Restasis

Placebo(without main component)

Arm Description

HU00701(Cyclosporine 0.01% + 3% trehalose) 1 drop b.i.d at 12 hour interval for 12 weeks

HU007(Cyclosporine 0.02% + 3% trehalose) 1 drop b.i.d at 12 hour interval for 12 weeks

Restasis(Cyclosporine 0.05%) 1 drop b.i.d at 12 hour interval for 12 weeks

Placebo 1 drop b.i.d at 12 hour interval for 12 weeks

Outcomes

Primary Outcome Measures

change from Baseline of Corneal staining score - Oxford grading

Secondary Outcome Measures

change from Baseline of Corneal staining score - Oxford grading
change from Baseline of Strip meniscometry assessment
change from Baseline of Tear film break-up time
change from Baseline of Standard patient evaluation of eye dryness questionnaire

Full Information

First Posted
September 26, 2016
Last Updated
April 10, 2018
Sponsor
Huons Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02917512
Brief Title
Efficacy and Safety Study of HU00701/HU007 Eye Drops in Patients With Dry Eye Syndrome
Official Title
A Multicenter, Placebo Controlled, Restasis® Referenced, Randomized, Double Blind, Phase II Study to Evaluate the Efficacy and Safety of HU00701/HU007 Eye Drops in Patients With Dry Eye Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Huons Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HU00701
Arm Type
Experimental
Arm Description
HU00701(Cyclosporine 0.01% + 3% trehalose) 1 drop b.i.d at 12 hour interval for 12 weeks
Arm Title
HU007
Arm Type
Experimental
Arm Description
HU007(Cyclosporine 0.02% + 3% trehalose) 1 drop b.i.d at 12 hour interval for 12 weeks
Arm Title
Restasis
Arm Type
Active Comparator
Arm Description
Restasis(Cyclosporine 0.05%) 1 drop b.i.d at 12 hour interval for 12 weeks
Arm Title
Placebo(without main component)
Arm Type
Placebo Comparator
Arm Description
Placebo 1 drop b.i.d at 12 hour interval for 12 weeks
Intervention Type
Drug
Intervention Name(s)
HU00701
Intervention Description
Cyclosporine 0.01% + 3% trehalose
Intervention Type
Drug
Intervention Name(s)
HU007
Intervention Description
Cyclosporine 0.02% + 3% trehalose
Intervention Type
Drug
Intervention Name(s)
Restasis
Intervention Description
Cyclosporine 0.05%
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Vehicle
Primary Outcome Measure Information:
Title
change from Baseline of Corneal staining score - Oxford grading
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
change from Baseline of Corneal staining score - Oxford grading
Time Frame
Week 4, 8
Title
change from Baseline of Strip meniscometry assessment
Time Frame
Week 4, 8, 12
Title
change from Baseline of Tear film break-up time
Time Frame
Week 4, 8, 12
Title
change from Baseline of Standard patient evaluation of eye dryness questionnaire
Time Frame
Week 4, 8, 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-il Baek
Organizational Affiliation
Huons Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Huons
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13486
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33449860
Citation
Shin J, Rho CR, Hyon JY, Chung TY, Yoon KC, Joo CK. A Randomized, Placebo-Controlled Phase II Clinical Trial of 0.01% or 0.02% Cyclosporin A with 3% Trehalose in Patients with Dry Eye Disease. J Ocul Pharmacol Ther. 2021 Jan-Feb;37(1):4-11. doi: 10.1089/jop.2020.0104.
Results Reference
derived

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

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