Health TrialsbyHealthPanel

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

ConditionSjögren's Syndrome
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGuangdong ProCapZoom Biosciences Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • MSCohi-O Lenses

    Drug

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

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: MSCohi-O Lenses GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events

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

Time frame
from subjects receiving administration to Day 29 post-administration

Secondary outcomes

1

corneal fluorescein staining

Changes in corneal fluorescein staining scores from baseline to Day 8, Day 15 and Day 29 post-administration.

Time frame
from baseline to Day 8, Day 15 and Day 29 post-administration
2

Tear film break-up time

Changes in Tear film break-up time from baseline on Day 8, Day 15 and Day 29 post-administration.

Time frame
from baseline on Day 8, Day 15 and Day 29 post-administration
3

ocular surface disease index scores

Changes in ocular surface disease index scores from baseline on Day 8, Day 15 and Day 29 post-administration

Time frame
from baseline on Day 8, Day 15 and Day 29 post-administration
4

Schirmer's test

Changes in Schirmer's test from baseline on Day 8, Day 15 and Day 29 post-administration.

Time frame
from baseline on Day 8, Day 15 and Day 29 post-administration

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangdong ProCapZoom Biosciences Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: