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| Name | Class |
|---|---|
| Samil Pharmaceutical Co., Ltd. | INDUSTRY |
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Comparison of Efficacy and Ocular Surface Disease Assessment Between Monoprost and BAK-preserved Latanoprost in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monoprost (preservative-free latanoprost eye drop) | Experimental | latanoprost : 1 drop once a day for 12 weeks to target eyes |
|
| Xalatan (preserved latanoprost eye drop) | Active Comparator | latanoprost : 1 drop once a day for 12 weeks to target eyes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monoprost | Drug | preservative-free latanoprost 1 drop once a day for 12 weeks to target eyes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Corneal staining test | The degree of staining of the cornea after blue fluorescein staining under the light of cobalt blue using a yellow filter was evaluated according to the Oxford grading system (0 to 5, the higher the worse) | (12-week-point) |
| Conjunctival staining test | The conjunctiva was divided into 6 areas and evaluated after the same staining method according to the Oxford grading system (0 to 3, the higher the worse) | (12-week-point) |
| Ocular surface disease index (OSDI) | The ocular surface was assessed using OSDI scoring questionnaire (0 to 100, the higher the worse) | (12-week-point) |
| Compliance check | Compliance of the drug administration has been check through the subject's self description (0 to 100, the higher the better) | (12-week-point) |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal staining test | The degree of staining of the cornea after blue fluorescein staining under the light of cobalt blue using a yellow filter was evaluated according to the Oxford grading system(0 to 5, the higher the worse) | (4-week-point) |
| Conjunctival staining test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seungsoo Rho, MD, PhD | CHA Bundang Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA University Bundang Medical Center | Seongnam | Bundang-gu | 13497 | South Korea |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| 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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| Xalatan | Drug | preserved latanoprost 1 drop once a day for 12 weeks to target eyes |
|
|
The conjunctiva was divided into 6 areas and evaluated after the same staining method according to the Oxford grading system (0 to 3, the higher the worse) |
| (4-week-point) |
| Ocular surface disease indext (OSDI) | The ocular surface was assessed using OSDI scoring questionnaire(0 to 100, the higher the worse) | (4-week-point) |
| IOP (intraocular pressure) | IOP was measured using Goldmann applanation tonometry and measured in mmHg. (numerical) | (4- / 12-week-point) |
| Tear break up time (TBUT) | The time taken from the last blink to the appearance of a black spot on the cornea after fluorescein dye staining. (second, numerical) | (4- / 12-week-point) |
| Limbal and bulbar hyperemia | The conjunctival hyperemia was assessed using Efron grading scales (0 to 4, the higher the worse) | (4- / 12-week-point) |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |