NCT03461575

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 5, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2018

Completed
Last Updated

May 8, 2020

Status Verified

April 1, 2018

Enrollment Period

6 months

First QC Date

March 5, 2018

Last Update Submit

May 6, 2020

Conditions

Dry Eye Syndrome

Outcome Measures

Primary Outcomes (1)

  • change from Baseline in Corneal staining(Oxford grading) score

    Week 12

Secondary Outcomes (7)

  • change from Baseline in Corneal staining(Oxford grading) score

    Week 4,8

  • change from Baseline of Conjunctival staining(Oxford grading) score

    Week 4,8,12

  • change from Baseline of Strip meniscometry assessment

    Week 4,8,12

  • change from Baseline of Tear film break-up time

    Week 4,8,12

  • change from Baseline of Standard patient evaluation of eye dryness questionnaire

    Week 4,8,12

  • +2 more secondary outcomes

Study Arms (3)

HU007

EXPERIMENTAL

Cyclosporine 0.02%, trehalose 3% 1 drop b.i.d at 12hr interval for 12 weeks

Drug: HU007

Restasis

ACTIVE COMPARATOR

Cyclosporine 0.05% 1 drop b.i.d at 12hr interval for 12 weeks

Drug: Restasis

Moisview

ACTIVE COMPARATOR

trehalose 3% 1 drop b.i.d at 12hr interval for 12 weeks

Drug: Moisview

Interventions

HU007DRUG

cyclosporine 0.02%, trehalose 3%

HU007
RestasisDRUG

cyclosporine 0.05%

Restasis
MoisviewDRUG

trehalose 3%

Moisview

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul ST.Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cyclosporins

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Namsick Kim

    Huons Co., Ltd.

    STUDY DIRECTOR

  • Choun-Ki Joo

    Seoul St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 12, 2018

Study Start

January 22, 2018

Primary Completion

July 12, 2018

Study Completion

July 12, 2018

Last Updated

May 8, 2020

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)