Trials Sponsors Conditions Drugs Pricing

Conditions

Sjögren's Syndrome

Outcome Measures

Primary Outcomes (1)

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 (4)

corneal fluorescein staining
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
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

Study Arms (1)

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

MSCohi-O LensesDrug

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

Also known as: MSCohi-O

MSCohi-O Lenses Group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Guangdong ProCapZoom Biosciences Co., Ltd.
Industrylead

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Jiexing Chen

CONTACT

18302002029 jxchen@procapzoom.com

Study Design

Study Type: interventional
Phase: early phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 9, 2025

First Posted

September 22, 2025

Study Start

September 12, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

August 30, 2026

Estimated (date passed)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

MSCohi-O Lenses Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

MSCohi-O Lenses Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record