Study to Evaluate the Efficacy and Safety of CKD-352 | NCT04548427

Studies
Study to Evaluate the Efficacy and Safety of CKD-352

NCT04548427

Sponsor

Chong Kun Dang Pharmaceutical

Status

Completed

Last Update Posted

Jun 1, 2021Actual

Enrollment

283Actual

Phase

Phase 3

Conditions

Dry Eye Disease

Interventions

CKD-352
Diquafosol Sodium 3%

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 22, 2020Actual

Primary Completion Date

May 7, 2021Actual

Completion Date

May 7, 2021Actual

First Submitted Date

Sep 10, 2020

First Submission Date that Met QC Criteria

Sep 10, 2020

First Posted Date

Sep 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2021

Last Update Posted Date

Jun 1, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

283Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CKD-352	Experimental		Drug: CKD-352
Diquafosol Sodium 3%	Active Comparator		Drug: Diquafosol Sodium 3%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CKD-352	Drug	Eye Drop	CKD-352
Diquafosol Sodium 3%

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in Corneal Staining from Baseline and at Week 4		Baseline, Week 4

Secondary Outcomes

Measure	Description	Time Frame
Changes in Corneal Staining from Baseline and at Week 2		Baseline, Week 2
Changes in Conjunctival Staining from Baseline and at Week 2,4		Baseline, Week 2,4

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jong Su Lee, M.D, Ph.D	Pusan National University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pusan National University Hospital		Pusan			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided