- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04448223
A Clinical Study to Evaluate the Efficacy and Safety of CKD-351
June 24, 2020 updated by: Chong Kun Dang Pharmaceutical
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
The purpose of this study is to evaluate efficacy and safety of CKD-351
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: KiHo Park
- Phone Number: +82-10-3458-3172
- Email: kihopark@snu.ac.kr
Study Locations
-
-
-
Seoul, Korea, Republic of
- Recruiting
- Seoul National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: CKD-351
|
Latanoprost (25ug/ml), Dorzolamide (20mg/ml), twice a day
|
ACTIVE_COMPARATOR: Latanoprost+Dorzolamide
Latanoprost(50ul/ml) Dorzolmamide(20mg/ml)
|
Latanoprost(50ug/ml) , once a day Dorzolmamide(20mg/ml), threetimes a day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mean intraocular pressure for efficacy measurement
Time Frame: Baseline, 4 weeks
|
Change in mean intraocular pressure at 4 weeks compared to baseline
|
Baseline, 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mean intraocular pressure for efficacy measurement
Time Frame: Baseline, 2 weeks
|
Change in mean intraocular pressure at 2 weeks compared to baseline
|
Baseline, 2 weeks
|
Changes in intraocular pressure for efficacy measurement
Time Frame: Baseline, 2 weeks, 4 weeks
|
Intraocular pressure by each measurement time
|
Baseline, 2 weeks, 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: KiHo Park, MD, Seoul National University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 11, 2020
Primary Completion (ANTICIPATED)
December 5, 2022
Study Completion (ANTICIPATED)
December 5, 2022
Study Registration Dates
First Submitted
May 11, 2020
First Submitted That Met QC Criteria
June 24, 2020
First Posted (ACTUAL)
June 25, 2020
Study Record Updates
Last Update Posted (ACTUAL)
June 25, 2020
Last Update Submitted That Met QC Criteria
June 24, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A71_04GLC1915
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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