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This study is a single-center, multiple-dosing, prospective, nonrandom, single-arm trial.
This study is a single-center, multiple-dosing, prospective, nonrandom, single-arm trial. To evaluate the clinical safety and efficacy of exosomes in patients with ocular involvement of Sjögren's syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exosome Preparation Group | Experimental | Each subject will have a single designated study eye; this eye will receive multiple instillations-one drop four times daily for 14 consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exosome Preparation | Drug | Each subject will have a single designated study eye; this eye will receive multiple instillations-one drop four times daily for 14 consecutive days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Incidence and severity of adverse events (AEs) from subjects receiving administration to Day 29 post-administration. | from subjects receiving administration to Day 29 post-administration |
| Measure | Description | Time Frame |
|---|---|---|
| CFS | Changes in corneal fluorescein staining (CFS) scores from baseline to Day 8, Day 15 and Day 29 post-administration. | from baseline to Day 8, Day 15 and Day 29 post-administration |
| TBUT | Changes in Tear film break-up time (TBUT) from baseline on Day 8, Day 15 and Day 29 post-administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiexing Chen | Contact | 18302002029 | jxchen@procapzoom.com |
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| ID | Term |
|---|---|
| D012859 | Sjogren's Syndrome |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| from baseline on Day 8, Day 15 and Day 29 post-administration |
| OSDI | Changes in ocular surface disease index (OSDI) scores from baseline on Day 8, Day 15 and Day 29 post-administration | from baseline on Day 8, Day 15 and Day 29 post-administration |
| Schirmer's test | Changes in Schirmer's test from baseline on Day 8, Day 15 and Day 29 post-administration. | from baseline on Day 8, Day 15 and Day 29 post-administration |
| D012216 |
| Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |