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Study to Evaluate the Efficacy and Safety of CKD-352

Primary Purpose

Dry Eye Disease

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-352
Diquafosol Sodium 3%
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 Disease focused on measuring Dry Eye Disease, CKD-352

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
  3. 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 clinically significant medical history of ocular disability
  3. Subjects who have malignant tumor within 5 years
  4. Subjects with known hypersensitivity to investigational product
  5. Women who are nursing, pregnant or planning pregnancy during the study
  6. Subjects who have received any other investigational product
  7. Impossible subjects who participate in clinical trial by investigator's decision

Sites / Locations

  • Pusan National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CKD-352

Diquafosol Sodium 3%

Arm Description

Outcomes

Primary Outcome Measures

Changes in Corneal Staining from Baseline and at Week 4

Secondary Outcome Measures

Changes in Corneal Staining from Baseline and at Week 2
Changes in Conjunctival Staining from Baseline and at Week 2,4
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
September 10, 2020
Last Updated
May 27, 2021
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT04548427
Brief Title
Study to Evaluate the Efficacy and Safety of CKD-352
Official Title
Active Controlled, Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-352 Eye Drops in Patients With Dry Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 22, 2020 (Actual)
Primary Completion Date
May 7, 2021 (Actual)
Study Completion Date
May 7, 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the efficacy and safety of CKD-352 in patients with dry eye disease
Detailed Description
Active controlled, randomized, double-blind, multi-center, phase 3 trial to evaluate the efficacy and safety of CKD-352 eye drops in patients with dry eye disease

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
Keywords
Dry Eye Disease, CKD-352

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
283 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CKD-352
Arm Type
Experimental
Arm Title
Diquafosol Sodium 3%
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
CKD-352
Intervention Description
Eye Drop
Intervention Type
Drug
Intervention Name(s)
Diquafosol Sodium 3%
Intervention Description
Eye Drop
Primary Outcome Measure Information:
Title
Changes in Corneal Staining from Baseline and at Week 4
Time Frame
Baseline, Week 4
Secondary Outcome Measure Information:
Title
Changes in Corneal Staining from Baseline and at Week 2
Time Frame
Baseline, Week 2
Title
Changes in Conjunctival Staining from Baseline and at Week 2,4
Time Frame
Baseline, Week 2,4
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 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 clinically significant medical history of ocular disability 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 Impossible subjects who participate in clinical trial by investigator's decision
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Su Lee, M.D, Ph.D
Organizational Affiliation
Pusan National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Pusan National University Hospital
City
Pusan
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study to Evaluate the Efficacy and Safety of CKD-352

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