MSCohi-O Lenses for Ocular Involvement in Sjögren's Syndrome | NCT07185139

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

NCT07185139

Sponsor

Guangdong ProCapZoom Biosciences Co., Ltd.

Status

Not yet recruiting

Last Update Posted

Sep 22, 2025Actual

Enrollment

12Estimated

Phase

Early Phase 1

Conditions

Sjögren's Syndrome

Interventions

MSCohi-O Lenses

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 12, 2025Estimated

Primary Completion Date

Aug 30, 2026Estimated

Completion Date

Sep 30, 2026Estimated

First Submitted Date

Sep 9, 2025

First Submission Date that Met QC Criteria

Sep 17, 2025

First Posted Date

Sep 22, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2025

Last Update Posted Date

Sep 22, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MSCohi-O Lenses Group	Experimental	Each subject will wear MSCohi-O Lenses for 12 hours a day, totally 14-day wearings.	Drug: MSCohi-O Lenses

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MSCohi-O Lenses	Drug	Each subject will wear MSCohi-O Lenses for 12 hours a day, totally 14 wearings.	MSCohi-O Lenses Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events	Incidence and severity of adverse events from subjects receiving administration to Day 29 post-administration.	from subjects receiving administration to Day 29 post-administration

Secondary Outcomes

Measure	Description	Time Frame
corneal fluorescein staining	Changes in corneal fluorescein staining 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
Tear film break-up time

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001172	Arthritis, Rheumatoid
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases