Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Evaluate the Efficacy and Safety of CKD-350

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02777723
Recruitment Status : Unknown
Verified May 2016 by Chong Kun Dang Pharmaceutical.
Recruitment status was:  Recruiting
First Posted : May 19, 2016
Last Update Posted : May 19, 2016
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

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

Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Drug: Xenobella Drug: Isotonic 0.3% Sodium Hyaluronate Phase 3

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 Start Date : May 2016
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CKD-350
Xenobella
Drug: Xenobella
Hypotonic 0.3% Sodium Hyaluronate
Other Name: Arm A

Active Comparator: Sodium Hyaluronate
Isotonic 0.3% Sodium Hyaluronate
Drug: Isotonic 0.3% Sodium Hyaluronate
Isotonic 0.3% Sodium Hyaluronate
Other Name: Arm B




Primary Outcome Measures :
  1. Changes in Corneal Staining by Oxford scale from Baseline and at Week 4 [ Time Frame: Baseline, week 4 ]

Secondary Outcome Measures :
  1. Changes in Corneal Staining by Oxford scale from Baseline and at Week 2 [ Time Frame: Baseline, week 2 ]
  2. Changes in Tear Break-up Time from Baseline and at Week 2, 4 [ Time Frame: Baseline, Week 2, 4 ]
  3. Changes in Schirmer I Test from Baseline and at Week 2, 4 [ Time Frame: Baseline, Week 2, 4 ]
  4. Changes in Ocular Surface Disease Index from Baseline and at week 2, 4 [ Time Frame: Baseline, week 2, 4 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02777723


Locations
Layout table for location information
Korea, Republic of
Chungnam National University Hospital Not yet recruiting
Daejeon, Chungcheongnam-do, Korea, Republic of
Contact: SiHwan Choi, MD    82-10-5427-7609    shchoi@cnu.ac.kr   
Seoul National University Bundang Hospital Recruiting
SeongNam, Gyeonggi-do, Korea, Republic of
Contact: JoonYoung Hyon, MD    82-10-2735-8123    jyhyon@snu.ac.kr   
Kyungpook National University Hospital Recruiting
Daegu, Gyeongsangbuk-do, Korea, Republic of
Contact: HongKyun Kim, MD    82-10-4509-4886    okeye@knu.ac.kr   
Pusan National University Hospital Recruiting
Busan, Gyeongsangnam-do, Korea, Republic of
Contact: JongSu Lee, MD    82-10-9021-2498    jongsool@pusan.ac.kr   
Chonbuk National University Hospital Recruiting
Jeonju, Jeollabuk-do, Korea, Republic of
Contact: InChun You, MD    82-10-3292-1824    you2ic@hanmail.net   
Chonnam National University Hospital Recruiting
Gwangju, Jeollanam-do, Korea, Republic of
Contact: KyungChul Yoon, MD    82-10-9220-0234    kcyoon@chonnam.ac.kr   
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: HungWon Tchah, MD    82-10-8177-8000    hwtchah@amc.seoul.kr   
Gangnam Severance Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: HyungKeun Lee, MD    82-10-6202-7164    shadik@yumc.yonsei.ac.kr   
Korea University ANAM Hospital Recruiting
Seoul, Korea, Republic of
Contact: HyoMyoung Kim, MD    82-10-5415-5776    hyomkim@daum.net   
Korea University GURO Hospital Recruiting
Seoul, Korea, Republic of
Contact: JongSeok Song, MD    82-10-9494-1606    song1606@gmail.com   
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: TaeYoung Chung, MD    82-10-9933-3563    tychung@skku.edu   
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: MeeKum Kim, MD    82-10-6277-0798    kmk9@snu.ac.kr   
The Catholic University of Korea Seoul ST. MARY'S Hospital Recruiting
Seoul, Korea, Republic of
Contact: SoHyang Chung, MD    82-10-6313-6202    chungsh@catholic.ac.kr   
Yonsei University Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: TaeIm Kim, MD    82-10-6309-9639    tikim@yumc.yonsei.ac.kr   
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Layout table for investigator information
Study Chair: HyoMyung Kim, MD Korea University Anam Hospital
Layout table for additonal information
Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT02777723    
Other Study ID Numbers: 164DES16001
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Chong Kun Dang Pharmaceutical:
Dry Eye Syndrome
Sodium Hyaluronate
CKD-350
Additional relevant MeSH terms:
Layout table for MeSH terms
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Syndrome
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents