MSCohi-O Lenses for Ocular Involvement in Sjögren's Syndrome

Not Applicable

Not yet recruiting

• Conditions: Sjögren's Syndrome
• Interventions: Drug: MSCohi-O Lenses

• Registration Number: NCT07185139
• Lead Sponsor: Guangdong ProCapZoom Biosciences Co., Ltd.

Brief Summary

This study is aSingle-center, multiple-dosing, prospective, nonrandom, single-arm trial.

Detailed Description

This study is aSingle-center, multiple-dosing, prospective, nonrandom, single-arm trial. To evaluate the clinical safety and efficacy of MSCohi-O Lenses in patients with ocular involvement of Sjögren's syndrome.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-09
• Study Start: 2025-09-12
• Study First Submitted QC: 2025-09-17
• Last Update Submitted: 2025-09-17
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22
• Primary Completion: 2026-08-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

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.
• Ocular signs and symptoms unresponsive to 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MSCohi-O Lenses Group	MSCohi-O Lenses	Each subject will wear MSCohi-O Lenses for 12 hours a day, totally 14-day wearings.

Primary Outcome Measures

Name	Time	Method
Adverse events	from subjects receiving administration to Day 29 post-administration	Incidence and severity of adverse events from subjects receiving administration to Day 29 post-administration.

Secondary Outcome Measures

Name	Time	Method
corneal fluorescein staining	from baseline to Day 8, Day 15 and Day 29 post-administration	Changes in corneal fluorescein staining scores from baseline to Day 8, Day 15 and Day 29 post-administration.
Tear film break-up time	from baseline on Day 8, Day 15 and Day 29 post-administration	Changes in Tear film break-up time from baseline on Day 8, Day 15 and Day 29 post-administration.
ocular surface disease index scores	from baseline on Day 8, Day 15 and Day 29 post-administration	Changes in ocular surface disease index 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.