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Dry Eye DiseasePhase 1/2NCT05738629

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

A Phase 1/2 study testing Pluripotent Stem Cell-derived Mesenchymal Stem Cell Exosome (PSC-MSC-Exo) Eye Drops in people with Dry Eye Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Dry Eye Disease
What is being tested?
Pluripotent Stem Cell-derived Mesenchymal Stem Cell Exosome (PSC-MSC-Exo) Eye Drops
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
Mar 2023to Feb 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

Qi Gao, Doc. contact

86-15088774002

gaoqi8977@zju.edu.cn

China1 site

  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University

    Hanzhou, Zhejiang, 310000

    Qi Gao, Doc, 86-15088774002

Other trials in China

About this study

Official title: 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

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

Read the 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

Conditions
Dry Eye Disease
Being tested
Pluripotent Stem Cell-derived Mesenchymal Stem Cell Exosome (PSC-MSC-Exo) Eye Drops
Keywords
dry eye disease; post refractive surgery; blepharospasm; exosomes; mesenchymal stem cell; pluripotent stem cell
Medical subject headings
Dry Eye Syndromes, Blepharospasm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pluripotent Stem Cell-derived Mesenchymal Stem Cell Exosome (PSC-MSC-Exo) Eye DropsDrug

    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.

Study groups in NCT05738629
Study groupRoleWhat they receive
PSC-MSC-Exo Eye Drops TreatmentExperimentalParticipants will receive artificial tears for 2 weeks to get the normalized baseline, followed by PSC-MSC-Exo eye drop intervention for 12 weeks.
Receives: Drug: Pluripotent Stem Cell-derived Mesenchymal Stem Cell Exosome (PSC-MSC-Exo) Eye Drops

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks

Secondary outcomes (9)

  1. 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.

    Measured: 1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks

  2. 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.

    Measured: 1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks

  3. 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.

    Measured: 1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks

  4. Best Corrected Visual Acuity (BCVA)

    Whether exosomes affect visual acuity.

    Measured: 1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks

  5. 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.

    Measured: 1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks

  6. 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.

    Measured: 1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks

  7. Corneal confocal microscopy

    The morphology, distribution and quantity of corneal nerve fibers were recorded by confocal image after LASIK and SMILE.

    Measured: 1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks

  8. 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.

    Measured: 1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks

  9. 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.

    Measured: 1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2023
  2. Study startMar 2023 (estimated)
  3. Primary completionFeb 2025 (estimated)
  4. Study completionFeb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05738629
Sponsor's protocol ID
2022-0290
Status last verified
Feb 2023
First submitted
13 Feb 2023
Last updated
22 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Randall Harrell C, Djonov V, Volarevic A, Arsenijevic A, Volarevic V. Mesenchymal Stem Cell-Sourced Exosomes as Potentially Novel Remedies for Severe Dry Eye Disease. J Ophthalmol. 2025 Jan 10;2025:5552374. doi: 10.1155/joph/5552374. eCollection 2025.

    PubMed 39839752

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pluripotent Stem Cell-derived Mesenchymal Stem Cell Exosome (PSC-MSC-Exo) Eye Drops in people with Dry Eye Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Qi Gao, Doc. (86-15088774002, gaoqi8977@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Ocular Surface Disease Index (OSDI) (time frame: 1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05738629, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.

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