Back to results

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

Primary Purpose

Dry Eye Syndrome

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

HU007

Restasis

Moisview

About this trial

This is an interventional treatment trial for Dry Eye Syndrome

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 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

Sites / Locations

Seoul ST.Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

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

Secondary Outcome Measures

change from Baseline in Corneal staining(Oxford grading) score

change from Baseline of Conjunctival staining(Oxford grading) score

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

arrival time of 100% clearence in Corneal staining test

The number of total rescue drug usage

Full Information

NCT ID

NCT03461575

First Posted

March 5, 2018

Last Updated

May 6, 2020

Sponsor

Huons Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03461575

Brief Title

Efficacy and Safety of HU007 Eye Drops 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

April 2018

Overall Recruitment Status

Completed

Study Start Date

January 22, 2018 (Actual)

Primary Completion Date

July 12, 2018 (Actual)

Study Completion Date

July 12, 2018 (Actual)

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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 Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

209 (Actual)

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

Intervention Description

trehalose 3%

Primary Outcome Measure Information:

Title

change from Baseline in Corneal staining(Oxford grading) score

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

change from Baseline in Corneal staining(Oxford grading) score

Time Frame

Week 4,8

Title

change from Baseline of Conjunctival staining(Oxford grading) score

Time Frame

Week 4,8,12

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

Title

arrival time of 100% clearence in Corneal staining test

Time Frame

Week 0-12

Title

The number of total rescue drug usage

Time Frame

Week 0-12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Namsick Kim

Organizational Affiliation

Huons Co., Ltd.

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Choun-Ki Joo

Organizational Affiliation

Seoul St. Mary's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul ST.Mary's Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs