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In patients with Glaucoma, Xalost S or Xalatan or Taflotan-S are administered for 12 weeks. After 12 weeks, among them, Xalatan administration group are switched to Xalost S or Taflotan-S. Extension study period is 8 weeks.
To compare effect (ocular surface damage) and safety of preservative-free Latanoprost/Tafluprost to Benzalkonium chloride-preserved Latanoprost in primary open angle glaucoma or normal tension glaucoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xalost S | Experimental |
| |
| Xalatan | Active Comparator |
| |
| Taflotan-S | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xalost S | Drug | One drop one times a day in study eye |
| |
| Xalatan |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Staining Score at week 12 | At week 12 of drug administration compare the therapeutic effectiveness between control drug and trial drug evaluated as the effect on corneal staining score. Scale: "Oxford grading system" that divides into 6 groups according to severity from 0 (absent) to 5 (severe). The higher scores mean a worse outcome. | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Hyperemia Score at week 4, 8, 12 | After 4, 8, 12 weeks of drug administration compare the therapeutic effectiveness between control drug and trial drug evaluated as the effect on Hyperemia Score. Scale: "Efron Grading Scales" that divided into 5 groups according to severity from 0 (normal) to 4 (severe). The higher scores mean a worse outcome. | baseline and week 4, 8, 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sukyoung Kwon, PhD | Contact | +82-2-799-0175 | skkwon@taejoon.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taejoon Pharmaceutical Co., Ltd. | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Drug |
One drop one times a day in study eye |
|
| Taflotan-S | Drug | One drop one times a day in study eye |
|
| Change from baseline in Intraocular Pressure at week 4, 8, 12 | After 4, 8, 12 weeks of drug administration compare the therapeutic effectiveness between control drug and trial drug evaluated as the effect on Intraocular pressure. The highest Intraocular pressure means a worse outcome. | baseline and week 4, 8, 12 |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |