A Clinical Study to Evaluate the Efficacy and Safety of CKD-351
NCT ID: NCT03762369
Last Updated: 2018-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
384 participants
INTERVENTIONAL
2018-12-07
2022-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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CKD-351
Latanoprost+D930
CKD-351
twice a day
D930
three times a day
Latanoprost
Latanoprost
once a day
Placebo of CKD-351
once a day
Placebo of D930
three times a day
D930
D930
three times a day
Placebo of CKD-351
twice a day
Interventions
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CKD-351
twice a day
Latanoprost
once a day
D930
three times a day
Placebo of CKD-351
once a day
Placebo of CKD-351
twice a day
Placebo of D930
three times a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects who has primary Open-Angle Glaucoma or Ocular Hypertension
3. Subjects who sign on an informed consent form willingly
Exclusion Criteria
2. Subjects with a maximum corrected visual acuity ≤ 0.3 in the selected evaluation eye at Visit 2
3. 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
4. Subjects with significant eye symptoms/signs(Abscesses, diplopia) or severe visual field impairment(Mean Deviation ≥ -25dB)
5. Subjects with severe dry eye syndrome or progressive retinal disease(Retinal degeneration, Diabetic retinopathy, Retinal detachment, Macular edema)
6. Subjects with inflammatory/infectious eye disease and active eye disease within the last 3 months
7. 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
8. Subjects who wore need to wear contact lenses during the study
9. Women who are nursing, pregnant or planning pregnancy during the study
10. Subjects with bronchial asthma or history
11. Subjects with severe renal impairment (creatinine clearance \<30 ml / min at screening) or hyperchloremic acidosis
12. Subjects who have received any other investigational product within 1 month prior to randomization
13. Impossible subjects who participate in clinical trial by investigator's decision
19 Years
ALL
No
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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KiHo Park
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hosipital
Locations
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Seoul National University Hosipital
Seoul, Jongno, South Korea
Countries
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Central Contacts
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Other Identifiers
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171GLC18006
Identifier Type: -
Identifier Source: org_study_id
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