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Safety and efficacy of DE-089 ophthalmic solution in patients with dry eye will be evaluated in comparison with sodium hyaluronate ophthalmic solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DE-089 | Experimental | DE-089 ophthalmic solution |
|
| HA | Active Comparator | 0.1% sodium hyaluronate ophthalmic solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diquafosol ophthalmic solution | Drug | DE-089 topical ocular application, 6 times daily for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the fluorescein and rose bengal staining score |
| 2 weeks and 4 weeks from baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in tear film breakup time (second) | Changes in tear film breakup time (second) 2 weeks, 4 week after the study / at the discontinuation | 2 weeks and 4 weeks from baseline. |
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Inclusion Criteria:
Those who show:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye & Ear Hospital of Fudan University | Shanghai | 200032 | China | |||
| Singapore Eye Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25631485 | Derived | Gong L, Sun X, Ma Z, Wang Q, Xu X, Chen X, Shao Y, Yao K, Tang L, Gu Y, Yuan H, Chua WH, Chuan JC, Tong L. A randomised, parallel-group comparison study of diquafosol ophthalmic solution in patients with dry eye in China and Singapore. Br J Ophthalmol. 2015 Jul;99(7):903-8. doi: 10.1136/bjophthalmol-2014-306084. Epub 2015 Jan 28. |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| 0.1% sodium hyaluronate ophthalmic solution. | Drug | 0.1% HA topical ocular application, 6 times daily for 4 weeks. |
|
| Singapore |
| Singapore |
| 168751 |
| Singapore |