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

April 10, 2018 updated by: Huons Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13486
        • Huons

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HU00701

HU00701(Cyclosporine 0.01% + 3% trehalose)

1 drop b.i.d at 12 hour interval for 12 weeks
Drug: HU00701
Cyclosporine 0.01% + 3% trehalose
EXPERIMENTAL: HU007

HU007(Cyclosporine 0.02% + 3% trehalose)

1 drop b.i.d at 12 hour interval for 12 weeks
Drug: HU007
Cyclosporine 0.02% + 3% trehalose
ACTIVE_COMPARATOR: Restasis

Restasis(Cyclosporine 0.05%)

1 drop b.i.d at 12 hour interval for 12 weeks
Drug: Restasis
Cyclosporine 0.05%
PLACEBO_COMPARATOR: Placebo(without main component)

Placebo

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change from Baseline of Corneal staining score - Oxford grading
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
change from Baseline of Corneal staining score - Oxford grading
Time Frame: Week 4, 8
Week 4, 8
change from Baseline of Strip meniscometry assessment
Time Frame: Week 4, 8, 12
Week 4, 8, 12
change from Baseline of Tear film break-up time
Time Frame: Week 4, 8, 12
Week 4, 8, 12
change from Baseline of Standard patient evaluation of eye dryness questionnaire
Time Frame: Week 4, 8, 12
Week 4, 8, 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huons Co., Ltd.

Investigators

  • Study Director: Seung-il Baek, Huons Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

September 26, 2016

First Submitted That Met QC Criteria

September 26, 2016

First Posted (ESTIMATE)

September 28, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 12, 2018

Last Update Submitted That Met QC Criteria

April 10, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HU-007_P2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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