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At present, research on cyclosporine mainly focuses on patients with moderate to severe dry eye. Based on the importance of the vicious cycle of inflammation in the pathogenesis of dry eye and the mechanism of cyclosporine, investigators believe that it may also have therapeutic effects in patients with mild to moderate dry eye, and may have certain advantages compared to traditional artificial tear therapy. In summary, this study intends to use a randomized, double-blind, parallel controlled trial to evaluate the therapeutic efficacy and safety of 0.05% cyclosporine eye drops in patients with mild to moderate dry eyes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.05% cyclosporine froup(Group C) | Experimental |
| |
| 0.1% sodium hyaluronate group(Group S) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.05% cyclosporine eyedrops | Drug | 0.05% cyclosporine, one drop each time, twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fluorescent tear film breakup time | 8weeks | |
| high-frequency component(HFC) | HFC represents a slight deformation of the lens in a state of relative modulation stillness, indicating tremors in the ciliary muscle | 8weeks |
| ASQ-17 | Asthenopia Survey Questionnaire (ASQ)-17,ASQ-17 covers 7 items of eye symptoms, 6 items of visual symptoms and 4 items of systemic and psychological symptoms with a total score of 51 and an optimal cut-off threshold value of 12.5[1]. [1]Lin N, Li XM, Yang MY, Tian L, Li ZH, Mao JL, Zhang JF, Chen J, Lyu F, Deng RZ. Development of a new 17-item Asthenopia Survey Questionnaire using Rasch analysis. Int J Ophthalmol. 2023 Nov 18;16(11):1867-1875. doi: 10.18240/ijo.2023.11.20. PMID: 38028524; PMCID: PMC10626358. | 8weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1 Xihu Avenue, Shangcheng District, Hangzhou, Zhejiang, China | Hangzhou | Zhejiang | China |
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| 0.1% sodium hyaluronate eye drop | Drug | 0.1% sodium hyaluronate, one drop each time, three times a day |
|
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D001248 | Asthenopia |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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