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

Primary Purpose

Primary Open Angle Glaucoma, Ocular Hypertension

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-351
Latanoprost+Dorzolmamide
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring Primary Open-angle Glaucoma, Ocular Hypertension, CKD-351

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 who has primary open-angle glaucoma or ocular hypertension
  3. Subjects who sign on an informed consent form willingly

Exclusion Criteria:

  1. Subjects with intraocular pressure ≥ 35 mmHg at Visit 1 or Visit 2 (AM 09:00)
  2. Subjects with a maximum corrected visual acuity ≤ 0.3 in the selected evaluation eye at Visit 1 or Visit 2

  3. Subjects who were diagnosed as below

    • Aphakia
    • Intraocular lens
    • Acute or Chronic Closed-Angle Glaucoma
    • Secondary Glaucoma
  4. Subjects with ocular inflammation or infection within the last 3 months
  5. Subjects with significant history of ocular trauma during the last 6 months or who underwent surgical opthalmic surgery
  6. Subjects who received topical or systemic steroids within the last 1 month.

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CKD-351

Latanoprost+Dorzolamide

Arm Description

CKD-351

Latanoprost(50ul/ml) Dorzolmamide(20mg/ml)

Outcomes

Primary Outcome Measures

Change in mean intraocular pressure for efficacy measurement
Change in mean intraocular pressure at 4 weeks compared to baseline

Secondary Outcome Measures

Change in mean intraocular pressure for efficacy measurement
Change in mean intraocular pressure at 2 weeks compared to baseline
Changes in intraocular pressure for efficacy measurement
Intraocular pressure by each measurement time

Full Information

First Posted
May 11, 2020
Last Updated
June 24, 2020
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT04448223
Brief Title
A Clinical Study to Evaluate the Efficacy and Safety of CKD-351
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 11, 2020 (Actual)
Primary Completion Date
December 5, 2022 (Anticipated)
Study Completion Date
December 5, 2022 (Anticipated)

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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma, Ocular Hypertension
Keywords
Primary Open-angle Glaucoma, Ocular Hypertension, CKD-351

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CKD-351
Arm Type
Experimental
Arm Description
CKD-351
Arm Title
Latanoprost+Dorzolamide
Arm Type
Active Comparator
Arm Description
Latanoprost(50ul/ml) Dorzolmamide(20mg/ml)
Intervention Type
Drug
Intervention Name(s)
CKD-351
Intervention Description
Latanoprost (25ug/ml), Dorzolamide (20mg/ml), twice a day
Intervention Type
Drug
Intervention Name(s)
Latanoprost+Dorzolmamide
Intervention Description
Latanoprost(50ug/ml) , once a day Dorzolmamide(20mg/ml), threetimes a day
Primary Outcome Measure Information:
Title
Change in mean intraocular pressure for efficacy measurement
Description
Change in mean intraocular pressure at 4 weeks compared to baseline
Time Frame
Baseline, 4 weeks
Secondary Outcome Measure Information:
Title
Change in mean intraocular pressure for efficacy measurement
Description
Change in mean intraocular pressure at 2 weeks compared to baseline
Time Frame
Baseline, 2 weeks
Title
Changes in intraocular pressure for efficacy measurement
Description
Intraocular pressure by each measurement time
Time Frame
Baseline, 2 weeks, 4 weeks

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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
KiHo Park
Phone
+82-10-3458-3172
Email
kihopark@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KiHo Park, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KiHo Park, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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