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Study to Evaluate the Efficacy and Safety of CKD-350

Primary Purpose

Dry Eye Syndrome

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Xenobella
Isotonic 0.3% Sodium Hyaluronate
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Dry Eye Syndrome, Sodium Hyaluronate, CKD-350

Eligibility Criteria

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

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

Sites / Locations

  • Chungnam National University Hospital
  • Seoul National University Bundang HospitalRecruiting
  • Kyungpook National University HospitalRecruiting
  • Pusan National University HospitalRecruiting
  • Chonbuk National University HospitalRecruiting
  • Chonnam National University HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Gangnam Severance Hospital
  • Korea University ANAM HospitalRecruiting
  • Korea University GURO HospitalRecruiting
  • Samsung Medical CenterRecruiting
  • Seoul National University Hospital
  • The Catholic University of Korea Seoul ST. MARY'S HospitalRecruiting
  • Yonsei University Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CKD-350

Sodium Hyaluronate

Arm Description

Xenobella

Isotonic 0.3% Sodium Hyaluronate

Outcomes

Primary Outcome Measures

Changes in Corneal Staining by Oxford scale from Baseline and at Week 4

Secondary Outcome Measures

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

Full Information

First Posted
May 15, 2016
Last Updated
May 17, 2016
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT02777723
Brief Title
Study to Evaluate the Efficacy and Safety of CKD-350
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 Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
Keywords
Dry Eye Syndrome, Sodium Hyaluronate, CKD-350

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CKD-350
Arm Type
Experimental
Arm Description
Xenobella
Arm Title
Sodium Hyaluronate
Arm Type
Active Comparator
Arm Description
Isotonic 0.3% Sodium Hyaluronate
Intervention Type
Drug
Intervention Name(s)
Xenobella
Other Intervention Name(s)
Arm A
Intervention Description
Hypotonic 0.3% Sodium Hyaluronate
Intervention Type
Drug
Intervention Name(s)
Isotonic 0.3% Sodium Hyaluronate
Other Intervention Name(s)
Arm B
Intervention Description
Isotonic 0.3% Sodium Hyaluronate
Primary Outcome Measure Information:
Title
Changes in Corneal Staining by Oxford scale from Baseline and at Week 4
Time Frame
Baseline, week 4
Secondary Outcome Measure Information:
Title
Changes in Corneal Staining by Oxford scale from Baseline and at Week 2
Time Frame
Baseline, week 2
Title
Changes in Tear Break-up Time from Baseline and at Week 2, 4
Time Frame
Baseline, Week 2, 4
Title
Changes in Schirmer I Test from Baseline and at Week 2, 4
Time Frame
Baseline, Week 2, 4
Title
Changes in Ocular Surface Disease Index from Baseline and at week 2, 4
Time Frame
Baseline, week 2, 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: More than the age of 19 years old Subjects with dry eye symptoms for at least 3 month prior to screening 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 Subjects who have a visual acuity equal to or better than 0.2 in both eyes Subjects who sign on an informed consent form willingly Exclusion Criteria: Subjects who have clinically significant ocular surface diseases, abnormal corneal susceptibility and abnormal epiphora 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 Subjects who have received occlusion therapy with lacrimal or punctal plugs within 3 months or have a surgery plan in clinical trial Subjects who wore contact lenses within 3 months or need to wear contact lenses during the study Subjects who take steroidal or immunosuppressive drug within 1 month Over 22mmHg IOP(Intraocular Pressure) Subjects who have malignant tumor within 5 years Subjects with known hypersensitivity to investigational product Women who are nursing, pregnant or planning pregnancy during the study Subjects who have received any other investigational product within 1 month prior to the first dosing Impossible subjects who participate in clinical trial by investigator's decision
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HyoMyung Kim, MD
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Chungnam National University Hospital
City
Daejeon
State/Province
Chungcheongnam-do
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SiHwan Choi, MD
Phone
82-10-5427-7609
Email
shchoi@cnu.ac.kr
Facility Name
Seoul National University Bundang Hospital
City
SeongNam
State/Province
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JoonYoung Hyon, MD
Phone
82-10-2735-8123
Email
jyhyon@snu.ac.kr
Facility Name
Kyungpook National University Hospital
City
Daegu
State/Province
Gyeongsangbuk-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HongKyun Kim, MD
Phone
82-10-4509-4886
Email
okeye@knu.ac.kr
Facility Name
Pusan National University Hospital
City
Busan
State/Province
Gyeongsangnam-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JongSu Lee, MD
Phone
82-10-9021-2498
Email
jongsool@pusan.ac.kr
Facility Name
Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
InChun You, MD
Phone
82-10-3292-1824
Email
you2ic@hanmail.net
Facility Name
Chonnam National University Hospital
City
Gwangju
State/Province
Jeollanam-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KyungChul Yoon, MD
Phone
82-10-9220-0234
Email
kcyoon@chonnam.ac.kr
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HungWon Tchah, MD
Phone
82-10-8177-8000
Email
hwtchah@amc.seoul.kr
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HyungKeun Lee, MD
Phone
82-10-6202-7164
Email
shadik@yumc.yonsei.ac.kr
Facility Name
Korea University ANAM Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HyoMyoung Kim, MD
Phone
82-10-5415-5776
Email
hyomkim@daum.net
Facility Name
Korea University GURO Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JongSeok Song, MD
Phone
82-10-9494-1606
Email
song1606@gmail.com
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TaeYoung Chung, MD
Phone
82-10-9933-3563
Email
tychung@skku.edu
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MeeKum Kim, MD
Phone
82-10-6277-0798
Email
kmk9@snu.ac.kr
Facility Name
The Catholic University of Korea Seoul ST. MARY'S Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SoHyang Chung, MD
Phone
82-10-6313-6202
Email
chungsh@catholic.ac.kr
Facility Name
Yonsei University Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TaeIm Kim, MD
Phone
82-10-6309-9639
Email
tikim@yumc.yonsei.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
No

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Study to Evaluate the Efficacy and Safety of CKD-350

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