Study to Evaluate the Efficacy and Safety of CKD-350

May 17, 2016 updated by: Chong Kun Dang Pharmaceutical

Active Controlled, Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-350 Eye Drops in Patients With Dry Eye Syndrome

The purpose of this study is to compare the efficacy and safety of CKD-350 in patients with dry eye syndrome

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Active controlled, randomized, double-blind, multi-center, phase 3 trial to evaluate the efficacy and safety of CKD-350 eye drops in patients with dry eye syndrome

Study Type

Interventional

Enrollment (Anticipated)

138

Phase

  • Phase 3

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
      • Seoul, Korea, Republic of
        • Recruiting
        • Asan Medical Center
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center
        • Contact:
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Korea University Anam Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Yonsei University Severance Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Korea University Guro Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • The Catholic University of Korea Seoul St. Mary'S Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Gangnam Severance Hospital
        • Contact:
    • Chungcheongnam-do
      • Daejeon, Chungcheongnam-do, Korea, Republic of
        • Not yet recruiting
        • Chungnam National University Hospital
        • Contact:
    • Gyeonggi-do
      • SeongNam, Gyeonggi-do, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
    • Gyeongsangbuk-do
      • Daegu, Gyeongsangbuk-do, Korea, Republic of
        • Recruiting
        • Kyungpook National University Hospital
        • Contact:
    • Gyeongsangnam-do
      • Busan, Gyeongsangnam-do, Korea, Republic of
        • Recruiting
        • Pusan National University Hospital
        • Contact:
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of
        • Recruiting
        • Chonbuk National University Hospital
        • Contact:
    • Jeollanam-do
      • Gwangju, Jeollanam-do, Korea, Republic of
        • Recruiting
        • Chonnam National University Hospital
        • Contact:

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. More than the age of 19 years old
  2. Subjects with dry eye symptoms for at least 3 month prior to screening
  3. Subjects who have following values 1) ≥ 2 point of corneal staining score 2) ≤ 10 seconds of Tear Break-up Time 3) ≤10mm/5min of Schirmer I Test
  4. Subjects who have a visual acuity equal to or better than 0.2 in both eyes
  5. Subjects who sign on an informed consent form willingly

Exclusion Criteria:

  1. Subjects who have clinically significant ocular surface diseases, abnormal corneal susceptibility and abnormal epiphora
  2. Subjects who have medical history following 1) Abnormal eyelids function including abnormality of eyelid or eyelash 2) Ophthalmology operation within 1 year 3) Active ocular infection at present or treatment of allergic eye diseases 4) Herpetic keratopathy, conjunctiva scar from cicatricial keratoconjunctivitis(alkali injuries, stevens-johnson syndrome, ocular cicatricial pemphigoid), pterygium, congenital lacrimal gland absence, neural keratitis, keratoconus
  3. Subjects who have received occlusion therapy with lacrimal or punctal plugs within 3 months or have a surgery plan in clinical trial
  4. Subjects who wore contact lenses within 3 months or need to wear contact lenses during the study
  5. Subjects who take steroidal or immunosuppressive drug within 1 month
  6. Over 22mmHg IOP(Intraocular Pressure)
  7. Subjects who have malignant tumor within 5 years
  8. Subjects with known hypersensitivity to investigational product
  9. Women who are nursing, pregnant or planning pregnancy during the study
  10. Subjects who have received any other investigational product within 1 month prior to the first dosing
  11. Impossible subjects who participate in clinical trial by investigator's decision

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: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CKD-350
Xenobella
Drug: Xenobella
Hypotonic 0.3% Sodium Hyaluronate
Other Names:
  • Arm A
ACTIVE_COMPARATOR: Sodium Hyaluronate
Isotonic 0.3% Sodium Hyaluronate
Drug: Isotonic 0.3% Sodium Hyaluronate
Isotonic 0.3% Sodium Hyaluronate
Other Names:
  • Arm B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in Corneal Staining by Oxford scale from Baseline and at Week 4
Time Frame: Baseline, week 4
Baseline, week 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in Corneal Staining by Oxford scale from Baseline and at Week 2
Time Frame: Baseline, week 2
Baseline, week 2
Changes in Tear Break-up Time from Baseline and at Week 2, 4
Time Frame: Baseline, Week 2, 4
Baseline, Week 2, 4
Changes in Schirmer I Test from Baseline and at Week 2, 4
Time Frame: Baseline, Week 2, 4
Baseline, Week 2, 4
Changes in Ocular Surface Disease Index from Baseline and at week 2, 4
Time Frame: Baseline, week 2, 4
Baseline, week 2, 4

Collaborators and Investigators

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

Sponsor

Chong Kun Dang Pharmaceutical

Investigators

  • Study Chair: HyoMyung Kim, MD, Korea University Anam Hospital

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

May 1, 2016

Primary Completion (ANTICIPATED)

July 1, 2016

Study Completion (ANTICIPATED)

September 1, 2016

Study Registration Dates

First Submitted

May 15, 2016

First Submitted That Met QC Criteria

May 17, 2016

First Posted (ESTIMATE)

May 19, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

May 19, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 164DES16001

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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