A Phase 1/2 interventional study of Pluripotent Stem Cell-derived Mesenchymal Stem Cell Exosome (PSC-MSC-Exo) Eye Drops in Dry Eye Disease, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-02-22.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 1/2, Interventional, and Treatment
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
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
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's planned enrollment of 12 is below the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive artificial tears for 2 weeks to get the normalized baseline, followed by PSC-MSC-Exo eye drop intervention for 12 weeks.
Drug: Pluripotent Stem Cell-derived Mesenchymal Stem Cell Exosome (PSC-MSC-Exo) Eye Drops
Participants will receive artificial tears for 2 weeks to get the normalized baseline, followed by PSC-MSC-Exo eye drops 0.125 ml/single eye/one time, four times a day for 12 weeks. The follow-up visit will be 12 weeks since the administration of PSC-MSC-Exo eye drops.
Change in Ocular Surface Disease Index (OSDI)
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.
Time frame: 1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks
Tear Secretion Test (Schirmer test)
A paper strip is placed on the eye under the lower lid for a specified time period. The length of the strip wetted by the tears was measured in millimeters. A positive change from baseline indicates an improvement in each eye.
Time frame: 1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks
Tear Film Break-up Time
Time required for dry spots to appear on the surface of the eye after blinking was measured in seconds. A positive change from baseline indicates improvement in each eye.
Time frame: 1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks
Ocular Surface Staining Score
Damage of the ocular surface was measured by slit-lamp examination after staining with non-toxic fluorescein sodium. Corneal and conjunctival staining were graded as per the National Eye Institute (NEI) pictorial scale. The lower the score, the less signs of dry eye disease a patient exhibits. A negative change from baseline indicates an improvement in each eye.
Time frame: 1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks
Best Corrected Visual Acuity (BCVA)
Whether exosomes affect visual acuity.
Time frame: 1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks
Conjunctiva Redness Score
Conjunctival hyperemia was graded in each eye under slit-lamp magnification by assigning a score of 0 to 4 for each quadrant based on comparison to the Allergan Dry Eye Redness Scale with photographic reference where: 0=Normal, vessels of bulbar conjunctiva are easily observed; 1=Trace redness; 2=Mild redness; 3=Moderate redness; 4=Severe redness, and each score is associated with a reference photo. A negative change from baseline indicates an improvement in each eye.
Time frame: 1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks
Tear Meniscus Height
The distance between the line of reflection along the top of the tear prism to the edge of the eyelid was measured in millimeters. A positive number change from baseline indicates improvement.
Time frame: 1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks
Corneal confocal microscopy
The morphology, distribution and quantity of corneal nerve fibers were recorded by confocal image after LASIK and SMILE.
Time frame: 1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks
Meibomian gland expressibility scores
Squeeze the central meibomian glands of the lower eyelid and assess the expressibility of the five central glands, where 0= All glands have meibum extruded, 1= 3-4 glands have meibum extruded, 2=1-2 glands have meibum extruded, 3=no glands have meibum extruded.
Time frame: 1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks
Meibomian Glands Photography
The morphology, quantity and blockage of meibomian gland can be assigned a score of 0 to 3 points according to meibomian gland dropout, where 0=normal without dropout; 1=meibomian gland dropout\<1/3; 2=meibomian gland dropout 1/3-2/3; 3=meibomian gland dropout \>2/3. The total score of upper and lower meibomian glands is 6 points, of which Grade 0=0-1 point; Grade 1=2-3 points; Grade 2=4-5 points; Grade 3=6 points.
Time frame: 1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks
Start is estimated for Mar 2023; primary completion for Feb 2025, 23 months later.
Of 21 phase 1/2 interventional studies under Dry Eye Syndromes, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 24. This study's planned 23 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University →