Safety and Efficacy of Pluripotent Stem Cell-derived Mesenchymal Stem Cell Exosome (PSC-MSC-Exo) … (NCT05738629) | Clinical Trial Compass
UnknownPhase 1/2
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
China12 participantsStarted 2023-03
Plain-language 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
Who can participate
Age range18 Years – 70 Years
SexALL
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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 kn…