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

NCT05738629 | Unknown Phase 1

• 1 other identifier: 2022-0290
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Dry Eye Disease

Keywords

dry eye disease; post refractive surgery; blepharospasm; exosomes; mesenchymal stem cell; pluripotent stem cell

Outcome Measures

Primary Outcomes (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.

  1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks

Secondary Outcomes (9)

• Tear Secretion Test (Schirmer test)

  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

• Ocular Surface Staining Score

  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

• Conjunctiva Redness Score

  1 weeks, 2 weeks, 4 weeks, 8 weeks,12 weeks

Study Arms (1)

PSC-MSC-Exo Eye Drops Treatment

EXPERIMENTAL

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

Interventions

Pluripotent Stem Cell-derived Mesenchymal Stem Cell Exosome (PSC-MSC-Exo) Eye Drops DRUG

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.

PSC-MSC-Exo Eye Drops Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Zhejiang University: collaborator
• Hangzhou yuansheng biotechnology Co., Ltd: collaborator

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hanzhou, Zhejiang, 310000, China

Location

Related Publications (1)

• 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.

  PMID: 39839752 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes; Blepharospasm

Interventions

Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Juan Ye, Doc.

  2nd Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Central Study Contacts

Qi Gao, Doc.

CONTACT

86-15088774002; gaoqi8977@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 22, 2023
• Study Start: March 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: February 22, 2023

Record last verified: 2023-02

Locations

CN (1)