Exploratory Trial to Evaluate the Efficacy and Safety of D565H Twice Daily Versus D565 Once Daily

Study Overview
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Brief Summary
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Exploratory trial to evaluate the efficacy and safety of D565H twice daily versus D565 once daily.

Detailed Description
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A Multi center, Randomized, Double-blind, Parallel design, Exploratory trial to evaluate the efficacy and safety of D565H twice daily versus D565 once daily in primary open angle glaucoma or ocular hypertension patients.

Official Title
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A Multi Center, Randomized, Double-blind, Parallel Design, Exploratory Trial to Evaluate the Efficacy and Safety of D565H Twice Daily Versus D565 Once Daily in Primary Open Angle Glaucoma or Ocular Hypertension Patients.

Conditions
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Glaucoma, Primary Open Angle, Ocular Hypertension

Intervention / Treatment
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* Drug: D565H(Latanoprost 25㎍/㎖)
* Drug: D565(Latanoprost 50㎍/㎖)


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) measured at Visit 1 and Visit 2(AM 09:00) above 35 mmHg at more than one eye Subjects with a maximum corrected visual acuity of less or than 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 or more) 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 Glaucoma surgery 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 6 months Subjects who wore need to wear contact lenses during the study Subjects who have drug interaction with the investigational product, have a significant effect on the intraocular pressure, or who may have an effect on the clinical trial results Subjects with known hypersensitivity to investigational product Women who are nursing, pregnant or planning pregnancy during the study Subjects with bronchial asthma or history Subjects who have received any other investigational product within 1 month prior to the first dosing 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
Interventional Model Description: Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D565H(Latanoprost 25㎍/㎖)<br>D565H(Latanoprost 25㎍/㎖) | Drug: D565H(Latanoprost 25㎍/㎖)<br>* D565H twice daily<br>* Other names: Arm A;Drug: D565(Latanoprost 50㎍/㎖)<br>* D565 once daily<br>* Other names: Arm B;|
| Active Comparator: D565(Latanoprost 50㎍/㎖)<br>D565(Latanoprost 50㎍/㎖) | Drug: D565H(Latanoprost 25㎍/㎖)<br>* D565H twice daily<br>* Other names: Arm A;Drug: D565(Latanoprost 50㎍/㎖)<br>* D565 once daily<br>* Other names: Arm B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean intraocular pressure at 4 weeks compared to baseline | Mean baseline intraocular pressure change Mean intraocular pressure change after 4 weeks | Baseline, 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean intraocular pressure at 2 weeks compared to baseline | Mean baseline intraocular pressure change Mean intraocular pressure change after 2 weeks | Baseline, 2 weeks | 
| Changes in intraocular pressure by measurement time | IOP variation by measurement time | 2 weeks, 4 weeks | 

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