Sjögren's Syndrome
Conditions
Brief summary
This study is a single-center, multiple-dosing, prospective, nonrandom, single-arm trial.
Detailed description
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.
Interventions
DRUGExosome Preparation
Each subject will have a single designated study eye; this eye will receive multiple instillations-one drop four times daily for 14 consecutive days.
Sponsors
Guangdong ProCapZoom Biosciences Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18-65 years old, including the boundary value, no gender restriction; * Subjects meeting the 2016 ACR/EULAR classification criteria for Sjögren's syndrome, and also meet the diagnostic criteria for ocular involvement. * The ocular involvement symptoms and signs of these patients cannot be relieved after at least 3 months of conventional therapy, including artificial tears and topical or systemic corticosteroids. * Extra-ocular manifestations of Sjögren's syndrome clinically stable. * Subjects and their partners agree to use effective non-pharmacological contraception from screening through 6 months after the last dose and have no plans for conception during this period. * Willing to participate in the study, understand and sign the informed consent form (ICF).
Exclusion criteria
* Known allergy to any component of the investigational drug. * Active ocular infection. * Presence of other significant ocular disease or trauma diagnosed prior to enrollment, including but not limited to glaucoma, uveitis, retinopathy, chemical injury, or thermal burns. * History of any ocular surgery within the preceding 6 months, including cataract surgery. * Participation in another interventional clinical study. * Use of any ophthalmic medication that may interfere with the study outcomes, such as other stem-cell-derived products. * Having serious underlying diseases of the heart, brain vessels, liver, kidneys, and hematopoietic system. * Pregnant or lactating women; women of childbearing potential must employ an effective contraceptive method (e.g., intrauterine device, oral contraceptive, or condom) during the study and for at least 3 months after the final dose of study drug. * Subjects deemed unsuitable for participation in this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs) | from subjects receiving administration to Day 29 post-administration | Incidence and severity of adverse events (AEs) from subjects receiving administration to Day 29 post-administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CFS | from baseline to Day 8, Day 15 and Day 29 post-administration | Changes in corneal fluorescein staining (CFS) scores from baseline to Day 8, Day 15 and Day 29 post-administration. |
| TBUT | from baseline on Day 8, Day 15 and Day 29 post-administration | Changes in Tear film break-up time (TBUT) from baseline on Day 8, Day 15 and Day 29 post-administration. |
| OSDI | from baseline on Day 8, Day 15 and Day 29 post-administration | Changes in ocular surface disease index (OSDI) scores from baseline on Day 8, Day 15 and Day 29 post-administration |
| Schirmer's test | from baseline on Day 8, Day 15 and Day 29 post-administration | Changes in Schirmer's test from baseline on Day 8, Day 15 and Day 29 post-administration. |
Contacts
Primary ContactJiexing Chen
Outcome results
None listed