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Exploratory trial to evaluate the efficacy and safety of D565H twice daily versus D565 once daily.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D565H(Latanoprost 25㎍/㎖) | Experimental | D565H(Latanoprost 25㎍/㎖) |
|
| D565(Latanoprost 50㎍/㎖) | Active Comparator | D565(Latanoprost 50㎍/㎖) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D565H(Latanoprost 25㎍/㎖) | Drug | D565H twice daily |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by the incidence of adverse event, History, Medication | Adverse events, history, medications, signs of vitality, physical examination, etc. | up to 4 weeks |
Inclusion Criteria:
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
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
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
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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 | Recruiting | 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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Assignment
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| D565(Latanoprost 50㎍/㎖) | Drug | D565 once daily |
|
|
IOP variation by measurement time
| 2 weeks, 4 weeks |