A Clinical Study of the 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
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Change in Ocular Surface Disease Index (OSDI)
Study Overview
Brief 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
Detailed Description
Dry eye disease (DED) is a multifactorial disease of the ocular surface characterized by instability of the tear film and the prevalence has been estimated to reach 20%-40%. Especially, dry eye symptoms are common complaints of patients with blepharospasm or refractive surgery history, seriously affecting their quality of life. There are many conventional therapies for DED which include ocular lubricants, oral essential fatty acid supplementation, lid hygiene and warm compresses, punctal occlusion, various treatments to obstructed meibomian glands, topical antibiotics, topical corticosteroids, topical secretagogues, topical non-glucocorticoid immunomodulatory drugs and scleral contact lenses. However, the overall efficacy is still unsatisfactory with apparent side effects, long periods of treatment, and high-costs. Mesenchymal stem cell-derived exosomes (MSC-Exo) are 30-150nm microvesicles secreted by mesenchymal stem cells (MSCs), which can mediate the therapeutic efficacy of mesenchymal stem cells by the encapsulated proteins, miRNAs and other bioactive substances, and showed potential in the treatment of various diseases. This study aims to evaluate the preliminary safety and effectiveness of PSC-MSC-Exo in the treatment of dry eye diseases post refractive surgery and associated with blepharospasm.
This is an open-label, single-arm, before-after study with 12 subjects with dry eye diseases and the history of refractive surgery or blepharospasm. There are 5 visits over the course of 12 weeks. Visit 1: Week-1 Visit 2: Week-2 Visit 3: Week-4 Visit 4: Week-8 Visit 5: Week-12
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
PSC-MSC-Exo Eye Drops Treatment
Participants will receive artificial tears for 2 weeks to get the normalized baseline, followed by PSC-MSC-Exo eye drop intervention for 12 weeks.
Intervention: Pluripotent Stem Cell-derived Mesenchymal Stem Cell Exosome (PSC-MSC-Exo) Eye Drops (Drug)
Outcomes
Primary Outcomes
Change in Ocular Surface Disease Index (OSDI)
Time Frame: 1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks
The OSDI questionnaire contains 12 questions to measure dry eye symptoms. OSDI scores range from 0 to 100. The lower the score, the more alleviation of dry eye symptoms. Compared with the baseline, a reduction of more than 10 points indicates improvement.
Secondary Outcomes
- Conjunctiva Redness Score(1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks)
- Tear Meniscus Height(1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks)
- Tear Secretion Test (Schirmer test)(1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks)
- Ocular Surface Staining Score(1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks)
- Tear Film Break-up Time(1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks)
- Best Corrected Visual Acuity (BCVA)(1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks)
- Corneal confocal microscopy(1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks)
- Meibomian gland expressibility scores(1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks)
- Meibomian Glands Photography(1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks)