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The study is being conducted to assess the efficacy, safety and tolerability of SHR8028 eye drops in comparison to the vehicle for the treatment of dry eye disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR8028 eye drops | Experimental |
| |
| Vehicle | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR8028 eye drops | Drug | SHR8028 eye drops |
| |
| Vehicle eye drops. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total corneal fluorescein staining (tCFS) score (National Eye Institute [NEI] scale) from baseline on Day 29 | Baseline, Day 29 | |
| Change in eye dryness score (visual analogue scale [VAS] Severity of Dryness) from baseline on Day 29 | Baseline, Day 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38451509 | Derived | Peng R, Jie Y, Long Q, Gong L, Zhu L, Zhong X, Zhao S, Yan X, Gu H, Wu H, Li G, Zhang K, Krosser S, Xu R, Hong J. Water-Free Cyclosporine Ophthalmic Solution vs Vehicle for Dry Eye Disease: A Randomized Clinical Trial. JAMA Ophthalmol. 2024 Apr 1;142(4):337-343. doi: 10.1001/jamaophthalmol.2024.0101. |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Drug |
Vehicle eye drops. |
|