Safety and Efficacy of Pluripotent Stem Cell-derived Mesenchymal Stem Cell Exosome (PSC-MSC-Exo) Eye Drops Treatment for Dry Eye Diseases Post Refractive Surgery and Associated With Blepharospasm

• Status: Not yet recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the preliminary safety and effectiveness of Pluripotent Stem Cell-derived Mesenchymal Stem Cell Exosome (PSC-MSC-Exo) Eye Drops in the treatment of dry eye diseases post refractive surgery and associated with blepharospasm

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Hangzhou yuansheng biotechnology Co., Ltd; Zhejiang University
• Treatments: Ophthalmic Solutions

Criteria

Inclusion Criteria:

• clinical diagnosis of apparent dry eye symptoms by ophthalmologists.

• patients experience dry eye symptoms with a definitive history of FS-LASIK or SMILE surgery, or blepharospasm, and previous application of artificial tears for more than 3 months could not relieve the dry eye symptoms.

• have the following symptoms in at least one eye: dryness, burning sensation, foreign body sensation, discomfort in the ocular surface or visual fatigue;

• tear secretion test (Schirmer's Test) of either eye ≤ 10 mm / 5 min;

• the corneal fluorescein staining score (FLCs) was more than 3 and less than 6.

• Tear break up time (TBUT) is less than 10 seconds.

Exclusion Criteria:

• Those who are allergic to any component of the drug in this study;

• Pregnant or nursing women;

• Patients with active fungal, bacterial or viral keratitis or conjunctivitis;

• have serious heart, lung, liver or kidney diseases;

• Other incurable ocular diseases before the study; such as glaucoma, uveitis, retinitis pigmentosa.

• Wearing contact lenses and unwilling to take off in the study;

• Performed ocular surgery (including cataract surgery) in recent three months;

• Enrolled in other interventional clinical studies at the same time;

• Application of eye drops that might affect the clinical study in the past 24 hours;

• Unable to complete the study according to the investigators' requirements;

• Application of eye drops other than artificial tears.

• Application of systemic medication known to reduce tear production, such as anti-anxiety drugs, antipsychotics and steroids.

• Eyelids or eyelashes anomaly.

• Serious systemic diseases.

• Refused to sign the informed consent form to participate in the experiment.