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:
PHASE3
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.
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 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
Key Trial Info
Start Date :
December 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2022
Estimated Enrollment :
384 Patients enrolled
Trial Details
Trial ID
NCT03762369
Start Date
December 7 2018
End Date
May 30 2022
Last Update
December 3 2018
Active Locations (1)
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1
Seoul National University Hosipital
Seoul, Jongno, South Korea