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
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
Treatments tested in this trial
- MSCohi-O Lenses
Treatment groups
12 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov