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, 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 patients

Official Title
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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 Patients

Conditions
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Primary Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: CKD-351
* Drug: Latanoprost+Dorzolmamide


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 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.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CKD-351<br>CKD-351 | Drug: CKD-351<br>* Latanoprost (25ug/ml), Dorzolamide (20mg/ml), twice a day<br>|
| Active Comparator: Latanoprost+Dorzolamide<br>Latanoprost(50ul/ml) Dorzolmamide(20mg/ml) | Drug: Latanoprost+Dorzolmamide<br>* Latanoprost(50ug/ml) , once a day Dorzolmamide(20mg/ml), threetimes 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 for efficacy measurement | Change in mean intraocular pressure at 4 weeks compared to baseline | Baseline, 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean intraocular pressure for efficacy measurement | Change in mean intraocular pressure at 2 weeks compared to baseline | Baseline, 2 weeks | 
| Changes in intraocular pressure for efficacy measurement | Intraocular pressure by each measurement time | Baseline, 2 weeks, 4 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