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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 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-351
Latanoprost
D930
Placebo of CKD-351
Placebo of CKD-351
Placebo of D930
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 IOP(Intraocular Pressure) ≥35 mmHg at Visit 1 and Visit 2 (AM 09:00) at more than one eye
  2. Subjects with a maximum corrected visual acuity ≤ 0.3 in the selected evaluation eye at Visit 2

  3. Subjects who were diagnosed as below with monocular or both eye

    • Acute or Chronic Closed-Angle Glaucoma
    • Secondary Glaucoma
    • Pseudoexfoliation Glaucoma
    • Neovascular Glaucoma
    • Aphakia
    • Phacocyst capsular torn intraocular lens
  4. Subjects with significant eye symptoms/signs(Abscesses, diplopia) or severe visual field impairment(Mean Deviation ≥ -25dB)
  5. Subjects with severe dry eye syndrome or progressive retinal disease(Retinal degeneration, Diabetic retinopathy, Retinal detachment, Macular edema)
  6. Subjects with inflammatory/infectious eye disease and active eye disease within the last 3 months

  7. Subjects who have medical history following

    • Subjects with significant history of ocular trauma during the last 6 months, or who underwent surgical ophthalmic surgery
    • Subjects who received topical or systemic steroids within the last 1 months
  8. Subjects who wore need to wear contact lenses during the study
  9. Women who are nursing, pregnant or planning pregnancy during the study
  10. Subjects with bronchial asthma or history
  11. Subjects with severe renal impairment (creatinine clearance <30 ml / min at screening) or hyperchloremic acidosis
  12. Subjects who have received any other investigational product within 1 month prior to randomization
  13. Impossible subjects who participate in clinical trial by investigator's decision

Sites / Locations

  • Seoul National University Hosipital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

CKD-351

Latanoprost

D930

Arm Description

Latanoprost+D930

Outcomes

Primary Outcome Measures

Change in mean intraocular pressure at 12 weeks compared to baseline

Secondary Outcome Measures

Change in mean intraocular pressure at 4 weeks, 8weeks compared to baseline
Changes in intraocular pressure by measurement time
IOP variation by measurement time

Full Information

First Posted
November 14, 2018
Last Updated
November 30, 2018
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT03762369
Brief Title
A Clinical Study to Evaluate the Efficacy and Safety of CKD-351
Official Title
Multi Center, Randomized, Double-blind, Active Controlled, Parallel Design, Phase 3 Trial 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
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 7, 2018 (Anticipated)
Primary Completion Date
February 28, 2022 (Anticipated)
Study Completion Date
May 30, 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, Double-blind, Active controlled, Parallel design, Phase 3 trial 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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
384 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CKD-351
Arm Type
Experimental
Arm Description
Latanoprost+D930
Arm Title
Latanoprost
Arm Type
Active Comparator
Arm Title
D930
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
CKD-351
Other Intervention Name(s)
Latanoprost+D930
Intervention Description
twice a day
Intervention Type
Drug
Intervention Name(s)
Latanoprost
Intervention Description
once a day
Intervention Type
Drug
Intervention Name(s)
D930
Intervention Description
three times a day
Intervention Type
Drug
Intervention Name(s)
Placebo of CKD-351
Intervention Description
once a day
Intervention Type
Drug
Intervention Name(s)
Placebo of CKD-351
Intervention Description
twice a day
Intervention Type
Drug
Intervention Name(s)
Placebo of D930
Intervention Description
three times a day
Primary Outcome Measure Information:
Title
Change in mean intraocular pressure at 12 weeks compared to baseline
Time Frame
Baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Change in mean intraocular pressure at 4 weeks, 8weeks compared to baseline
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Changes in intraocular pressure by measurement time
Description
IOP variation by measurement time
Time Frame
4 weeks, 8 weeks, 12 weeks
Other Pre-specified Outcome Measures:
Title
Safety assessed by number of participants with treatment-related adverse events
Time Frame
up to 24 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 IOP(Intraocular Pressure) ≥35 mmHg at Visit 1 and Visit 2 (AM 09:00) at more than one eye Subjects with a maximum corrected visual acuity ≤ 0.3 in the selected evaluation eye at Visit 2 Subjects who were diagnosed as below with monocular or both eye Acute or Chronic Closed-Angle Glaucoma Secondary Glaucoma Pseudoexfoliation Glaucoma Neovascular Glaucoma Aphakia Phacocyst capsular torn intraocular lens Subjects with significant eye symptoms/signs(Abscesses, diplopia) or severe visual field impairment(Mean Deviation ≥ -25dB) Subjects with severe dry eye syndrome or progressive retinal disease(Retinal degeneration, Diabetic retinopathy, Retinal detachment, Macular edema) Subjects with inflammatory/infectious eye disease and active eye disease within the last 3 months Subjects who have medical history following Subjects with significant history of ocular trauma during the last 6 months, or who underwent surgical ophthalmic surgery Subjects who received topical or systemic steroids within the last 1 months Subjects who wore need to wear contact lenses during the study Women who are nursing, pregnant or planning pregnancy during the study Subjects with bronchial asthma or history Subjects with severe renal impairment (creatinine clearance <30 ml / min at screening) or hyperchloremic acidosis Subjects who have received any other investigational product within 1 month prior to randomization Impossible subjects who participate in clinical trial by investigator's decision
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
Organizational Affiliation
Seoul National University Hosipital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hosipital
City
Seoul
State/Province
Jongno
Country
Korea, Republic of

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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