A Clinical Study to Evaluate the Efficacy and Safety of CKD-351

Study Overview
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Brief Summary
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The purpose of this study is to evaluate efficacy and safety of CKD-351.

Detailed Description
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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.

Official Title
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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

Conditions
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Primary Open-angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: CKD-351
* Drug: Latanoprost
* Drug: D930
* Drug: Placebo of CKD-351
* Drug: Placebo of CKD-351
* Drug: Placebo of D930


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CKD-351<br>Latanoprost+D930 | Drug: CKD-351<br>* twice a day<br>* Other names: Latanoprost+D930;Drug: D930<br>* three times a day<br>|
| Active Comparator: Latanoprost<br> | Drug: Latanoprost<br>* once a day<br>Drug: Placebo of CKD-351<br>* once a day<br>Drug: Placebo of D930<br>* three times a day<br>|
| Active Comparator: D930<br> | Drug: D930<br>* three times a day<br>Drug: Placebo of CKD-351<br>* twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean intraocular pressure at 12 weeks compared to baseline |  | Baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 4 weeks, 8 weeks, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Open-angle Glaucoma, Ocular Hypertension, CKD-351