A Clinical Study to Evaluate the Efficacy and Safety of C... | NCT04448223

Studies
A Clinical Study to Evaluate the Efficacy and Safety of CKD-351

NCT04448223

Sponsor

Chong Kun Dang Pharmaceutical

Status

Unknown status

Last Update Posted

Jun 25, 2020Actual

Enrollment

100Estimated

Phase

Phase 2

Conditions

Primary Open Angle Glaucoma
Ocular Hypertension

Interventions

CKD-351
Latanoprost+Dorzolmamide

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

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 11, 2020Actual

Primary Completion Date

Dec 5, 2022Estimated

Completion Date

Dec 5, 2022Estimated

First Submitted Date

May 11, 2020

First Submission Date that Met QC Criteria

Jun 24, 2020

First Posted Date

Jun 25, 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

Jun 24, 2020

Last Update Posted Date

Jun 25, 2020Actual

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 evaluate efficacy and safety of CKD-351

Detailed Description

Multi center, Randomized, Open-label, Active controlled, Phase 2 trial, Proof Of Concept Study to evaluate the efficacy and safety of CKD-351 in primary open angle glaucoma or ocular hypertension patients

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CKD-351	Experimental	CKD-351	Drug: CKD-351
Latanoprost+Dorzolamide	Active Comparator	Latanoprost(50ul/ml) Dorzolmamide(20mg/ml)	Drug: Latanoprost+Dorzolmamide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CKD-351	Drug	Latanoprost (25ug/ml), Dorzolamide (20mg/ml), twice a day	CKD-351

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in mean intraocular pressure for efficacy measurement	Change in mean intraocular pressure at 4 weeks compared to baseline	Baseline, 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in mean intraocular pressure for efficacy measurement	Change in mean intraocular pressure at 2 weeks compared to baseline	Baseline, 2 weeks
Changes in intraocular pressure for efficacy measurement

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

More than the age of 19 years old
Subjects who has primary open-angle glaucoma or ocular hypertension
Subjects who sign on an informed consent form willingly

Exclusion Criteria:

Subjects with intraocular pressure ≥ 35 mmHg at Visit 1 or Visit 2 (AM 09:00)
Subjects with a maximum corrected visual acuity ≤ 0.3 in the selected evaluation eye at Visit 1 or Visit 2
Subjects who were diagnosed as below
- Aphakia
- Intraocular lens
- Acute or Chronic Closed-Angle Glaucoma
- Secondary Glaucoma
Subjects with ocular inflammation or infection within the last 3 months
Subjects with significant history of ocular trauma during the last 6 months or who underwent surgical opthalmic surgery
Subjects who received topical or systemic steroids within the last 1 month.

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

Name	Role	Phone	Extension	Email
KiHo Park	Contact	+82-10-3458-3172		kihopark@snu.ac.kr

Overall Officials

Name	Affiliation	Role
KiHo Park, MD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital	Recruiting	Seoul			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

ID	Term
D005902	Glaucoma, Open-Angle
D009798	Ocular Hypertension

ID	Term
D005901	Glaucoma
D005128	Eye Diseases