A Clinical Study to Evaluate the Efficacy and Safety of CKD-351
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
1 other identifier
interventional
100
1 country
1
Brief Summary
The purpose of this study is to evaluate efficacy and safety of CKD-351
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2020
CompletedStudy Start
First participant enrolled
June 11, 2020
CompletedFirst Posted
Study publicly available on registry
June 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2022
CompletedJune 25, 2020
June 1, 2020
2.5 years
May 11, 2020
June 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in mean intraocular pressure for efficacy measurement
Change in mean intraocular pressure at 4 weeks compared to baseline
Baseline, 4 weeks
Secondary Outcomes (2)
Change in mean intraocular pressure for efficacy measurement
Baseline, 2 weeks
Changes in intraocular pressure for efficacy measurement
Baseline, 2 weeks, 4 weeks
Study Arms (2)
CKD-351
EXPERIMENTALCKD-351
Latanoprost+Dorzolamide
ACTIVE COMPARATORLatanoprost(50ul/ml) Dorzolmamide(20mg/ml)
Interventions
Latanoprost(50ug/ml) , once a day Dorzolmamide(20mg/ml), threetimes a day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
KiHo Park, MD
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2020
First Posted
June 25, 2020
Study Start
June 11, 2020
Primary Completion
December 5, 2022
Study Completion
December 5, 2022
Last Updated
June 25, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share