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The purpose of this study is to evaluate efficacy and safety of CKD-351.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CKD-351 | Experimental | Latanoprost+D930 |
|
| Latanoprost | Active Comparator |
| |
| D930 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-351 | Drug | twice a day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean intraocular pressure at 12 weeks compared to baseline | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean intraocular pressure at 4 weeks, 8weeks compared to baseline | Baseline, 4 weeks, 8 weeks | |
| Changes in intraocular pressure by measurement time | IOP variation by measurement time |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by number of participants with treatment-related adverse events | up to 24 weeks |
Inclusion Criteria:
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
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 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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| KiHo Park | Contact | 82-10-3458-3172 | kihopark@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| KiHo Park | Seoul National University Hosipital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hosipital | Seoul | Jongno | South Korea |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Latanoprost |
| Drug |
once a day |
|
| D930 | Drug | three times a day |
|
| Placebo of CKD-351 | Drug | once a day |
|
| Placebo of CKD-351 | Drug | twice a day |
|
| Placebo of D930 | Drug | three times a day |
|
| 4 weeks, 8 weeks, 12 weeks |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |