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The objective of this study was to investigate the improving effect of corneal disorder in primary open-angle glaucoma and ocular hypertension patients, when switched from the 0.005% latanoprost ophthalmic solution (one drop at a time, once daily) to the 0.0015% tafluprost ophthalmic solution (one drop at a time, once daily). Efficacy also was investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| latanoprost switch to tafluprost | Experimental | POAG and OH patients prescribed latanoprost(QID) at least 3 months (IOP>20). At least one eye must have a score above 1 on the NEI scale. Switch to latanoprost (QID) for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Latanoprost | Drug | latanoprost 0.05%(one drop, once daily) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Changes in the Intraocular Pressure (IOP) at each visit | Tonometer | 3 months |
| Safety:Changes in the fluorescein staining score (NEI) at Visit 2 | fluorescein staining | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the fluorescein staining score (NEI) at Visit 1 | fluorescein staining | 1 months |
| Changes in ocular symptoms (irritation/burning/stinging, foreign body sensation, tearing, itching and dry eye sensation) at each visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chi Mei Hospital Liouying Branch | Tainan | Taiwan |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 15, 2021 | |
| Reset | Jul 9, 2021 |
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| tafluprost |
| Drug |
tafluprost 0.015% (one drop, once daily) |
|
Questionnaire
| 3 months |
| Changes in the Tear Break-Up Time (TBUT) at each visit | slit-lamp | 3 months |
| Changes in the hyperaemia at each visit | slit-lamp | 3 months |
| Treatment compliance | Questionnaire | 3 months |
| Concomitant medication | Questionnaire | 3 months |
| Patient satisfaction about test medication | Questionnaire | 3 months |
| Usability of eyedrop bottle | Questionnaire | 3 months |
| Adverse drug reactions | Questionnaire | 3 months |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 15, 2021 | Jul 9, 2021 |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| C485333 | tafluprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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