Status:
UNKNOWN
A Clinical Study to Evaluate the Efficacy and Safety of CKD-351
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Primary Open Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
19+ years
Phase:
PHASE2
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 pati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 5 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04448223
Start Date
June 11 2020
End Date
December 5 2022
Last Update
June 25 2020
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea