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

Exploratory Clinical Trial of MSCohi-O Lenses for Ocular Involvement in Sjögren's Syndrome

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

Study Overview

• Status: Not yet recruiting
• Conditions: Sjögren's Syndrome
• Intervention / Treatment: Drug: MSCohi-O Lenses

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 Type: Interventional
• Enrollment (Estimated): 12
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Jiexing Chen; Phone Number: 18302002029; Email: jxchen@procapzoom.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MSCohi-O Lenses Group; Each subject will wear MSCohi-O Lenses for 12 hours a day, totally 14-day wearings.	Drug: MSCohi-O Lenses; Each subject will wear MSCohi-O Lenses for 12 hours a day, totally 14 wearings.; Other Names: MSCohi-O

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	Changes in Tear film break-up time from baseline on Day 8, Day 15 and Day 29 post-administration.	from baseline on Day 8, Day 15 and Day 29 post-administration
ocular surface disease index scores	Changes in ocular surface disease index 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

Collaborators and Investigators

• Sponsor: Guangdong ProCapZoom Biosciences Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): September 12, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: September 9, 2025
• First Submitted That Met QC Criteria: September 17, 2025
• First Posted (Actual): September 22, 2025

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Skin and Connective Tissue Diseases; Sjogren's Syndrome
• Other Study ID Numbers: PLKR-MSCohi-O-501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No