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HU007 Eye Drops in Patients With Dry Eye Syndrome

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HU007
Restasis eye drop
Sponsored by
Huons Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

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

Inclusion Criteria:

  • Male and Female who over 19 years old

  • Those who meet below criteria at least one of two eyes

    1. Those who have over than score 2 in corneal staining test-Oxford grading
    2. Tear secretion test without anesthesia(Schirmer test) result would be under 10mm/5min (If the test result is 0mm/5min, it should be over than 3mm/5min on the nasal stimulation schirmer test in the same eye)
    3. TBUT(Tear film break-up time) test result should be under 10sec.
  • Woman with no possibility of pregnancy or negative pregnancy test results at a screening visit, Women or men who have agreed to maintain at least one contraceptive method during study period
  • Those who could understand this study and agree to informed consent voluntarily

Exclusion Criteria:

  • Those who have clinically significant eye disease not related to dry eye symdrome
  • Those who are in anti-inflammatory medication for dry eye syndrome
  • Medication of systemic steroid or immunosuppressant
  • Those who have worn contact lenses before 72hours or have to wear contact lenses or disagree not to wear contact lenses during study period
  • Those who have medical history with intraocular surgery 90 days before screening visit
  • Those who have any active ophthalmic diseases such as active allergy, anterior uveitis, stevens-johnson syndrom which could affect the surfece of eye
  • Those who have any autoimmune diseases
  • Those who need a surgery for surface elevation caused by meibomian gland dysfunction(MGD)
  • Those who have any medical history of corneal transplantation or neurotrophic keratitis
  • Those who have diagnosed with glaucoma or have an intraocular pressure over than 25mmHg at least in one of the eyes
  • Those who have medicated cyclosporine or steroid eye-drops 30 days before screening visit
  • Those who have underwent any eye correction surgery such as LASIK(Laser-assistant in situ keratomileusis) 12 months before screening visit
  • Those who have underwent a silicone lacrimal punctal occlusion or cauterization of the punctum excluding collagen lacrimal punctal occlusion 90 days before screening visit
  • Those who have a hypersensitivity reaction for cyclosporine, trehalose or protein-based medication related to investigational drug
  • Those who have diagnosed a psychical disorder which could affect this study
  • Women who is pregnant or breastfeeding or those who have a plan to be pregnant
  • Those who have medical history on abusing medications or alchol
  • Those who have received other investigational drugs/devices 30 days before screening visit
  • Those who are inappropriate for participating in this study according to investigator's judgement

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HU007 Eye drop

Restasis Eye drop 0.05% (Cyclosporine)

Arm Description

Adminster twice a day(one drop would be administered to both eyes once a time). When being administered, the IP should be mixed by upside down. Medication is recommended at 9AM(±1H) and 9PM(±1H)

Adminster twice a day(one drop would be administered to both eyes once a time). When being administered, the IP should be mixed by upside down. Medication is recommended at 9AM(±1H) and 9PM(±1H)

Outcomes

Primary Outcome Measures

Change from baseline in corneal staining score-Oxford grading
Change from baseline in corneal staining score-Oxford grading at Week 12

Secondary Outcome Measures

Change from baseline in corneal staining score-Oxford grading
Change from baseline in corneal staining score-Oxford grading at Week 4, 8
Change from baseline in conjunctival staining score-Oxford grading
Change from baseline in conjunctival staining score-Oxford grading at Week 4, 8, 12
Change from baseline in strip meniscometry
Change from baseline in strip meniscometry at Week 4, 8, 12
Change from baseline in Tear film break-up time
Change from baseline in Tear film break-up time at Week 4, 8, 12
Change from Baseline of Standard patient evaluation of eye dryness questionnaire
Change from Baseline of Standard patient evaluation of eye dryness questionnaire at Week 4, 8, 12
Time to achieve 100% clearance on the corneal staining score
Time to achieve 100% clearance on the corneal staining score

Full Information

First Posted
August 16, 2019
Last Updated
May 11, 2020
Sponsor
Huons Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04384991
Brief Title
HU007 Eye Drops in Patients With Dry Eye Syndrome
Official Title
A Multicenter, Randomized, Double Blind, Restasis-controlled Non-inferiority, 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
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 3, 2019 (Actual)
Primary Completion Date
December 5, 2019 (Actual)
Study Completion Date
December 5, 2019 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is a multicenter, randomized, double blind, Restasis-controlled non-inferiority, 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 Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HU007 Eye drop
Arm Type
Experimental
Arm Description
Adminster twice a day(one drop would be administered to both eyes once a time). When being administered, the IP should be mixed by upside down. Medication is recommended at 9AM(±1H) and 9PM(±1H)
Arm Title
Restasis Eye drop 0.05% (Cyclosporine)
Arm Type
Active Comparator
Arm Description
Adminster twice a day(one drop would be administered to both eyes once a time). When being administered, the IP should be mixed by upside down. Medication is recommended at 9AM(±1H) and 9PM(±1H)
Intervention Type
Drug
Intervention Name(s)
HU007
Intervention Description
Cyclosporine 0.02% with Trehalose 3%
Intervention Type
Drug
Intervention Name(s)
Restasis eye drop
Intervention Description
Cyclosporine 0.05%
Primary Outcome Measure Information:
Title
Change from baseline in corneal staining score-Oxford grading
Description
Change from baseline in corneal staining score-Oxford grading at Week 12
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change from baseline in corneal staining score-Oxford grading
Description
Change from baseline in corneal staining score-Oxford grading at Week 4, 8
Time Frame
Week 4, 8
Title
Change from baseline in conjunctival staining score-Oxford grading
Description
Change from baseline in conjunctival staining score-Oxford grading at Week 4, 8, 12
Time Frame
Week 4, 8, 12
Title
Change from baseline in strip meniscometry
Description
Change from baseline in strip meniscometry at Week 4, 8, 12
Time Frame
Week 4, 8, 12
Title
Change from baseline in Tear film break-up time
Description
Change from baseline in Tear film break-up time at Week 4, 8, 12
Time Frame
at Week 4, 8, 12
Title
Change from Baseline of Standard patient evaluation of eye dryness questionnaire
Description
Change from Baseline of Standard patient evaluation of eye dryness questionnaire at Week 4, 8, 12
Time Frame
at Week 4, 8, 12
Title
Time to achieve 100% clearance on the corneal staining score
Description
Time to achieve 100% clearance on the corneal staining score
Time Frame
upto week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and Female who over 19 years old Those who meet below criteria at least one of two eyes Those who have over than score 2 in corneal staining test-Oxford grading Tear secretion test without anesthesia(Schirmer test) result would be under 10mm/5min (If the test result is 0mm/5min, it should be over than 3mm/5min on the nasal stimulation schirmer test in the same eye) TBUT(Tear film break-up time) test result should be under 10sec. Woman with no possibility of pregnancy or negative pregnancy test results at a screening visit, Women or men who have agreed to maintain at least one contraceptive method during study period Those who could understand this study and agree to informed consent voluntarily Exclusion Criteria: Those who have clinically significant eye disease not related to dry eye symdrome Those who are in anti-inflammatory medication for dry eye syndrome Medication of systemic steroid or immunosuppressant Those who have worn contact lenses before 72hours or have to wear contact lenses or disagree not to wear contact lenses during study period Those who have medical history with intraocular surgery 90 days before screening visit Those who have any active ophthalmic diseases such as active allergy, anterior uveitis, stevens-johnson syndrom which could affect the surfece of eye Those who have any autoimmune diseases Those who need a surgery for surface elevation caused by meibomian gland dysfunction(MGD) Those who have any medical history of corneal transplantation or neurotrophic keratitis Those who have diagnosed with glaucoma or have an intraocular pressure over than 25mmHg at least in one of the eyes Those who have medicated cyclosporine or steroid eye-drops 30 days before screening visit Those who have underwent any eye correction surgery such as LASIK(Laser-assistant in situ keratomileusis) 12 months before screening visit Those who have underwent a silicone lacrimal punctal occlusion or cauterization of the punctum excluding collagen lacrimal punctal occlusion 90 days before screening visit Those who have a hypersensitivity reaction for cyclosporine, trehalose or protein-based medication related to investigational drug Those who have diagnosed a psychical disorder which could affect this study Women who is pregnant or breastfeeding or those who have a plan to be pregnant Those who have medical history on abusing medications or alchol Those who have received other investigational drugs/devices 30 days before screening visit Those who are inappropriate for participating in this study according to investigator's judgement
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD would be substituted for screening or random No.

Learn more about this trial

HU007 Eye Drops in Patients With Dry Eye Syndrome

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