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New treatment option for Dry Eye Disease
Official title Human Umbilical Cord Mesenchymal Stem Cell-derived Small Extracellular Vesicles for the Treatment of Dry Eye Disease
ClinicalTrials.gov ID: NCT07623382
What this study is testing
What is Human umbilical cord mesenchymal stem cell-derived small extracellular vesicle (sEV) eye drops.?
Human umbilical cord mesenchymal stem cell-derived small extracellular vesicle (sEV) eye drops. is an investigational medicine, given as an once-weekly treatment applied to the skin, being studied as a potential treatment for dry eye disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical trial aims to preliminarily evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell small extracellular vesicle eye drops in patients with dry eye disease. 1.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people who voluntarily participate and sign the informed consent form, are willing to comply with the treatment schedule specified in the study...
- Aged ≥ 18 years, with no gender restriction.
- Best-corrected visual acuity (BCVA) of both eyes (OU) ≥ 0.1 at the Screening Visit (Visit 1, V1).
- History of dry eye disease in both eyes prior to the Screening Visit (Visit 1, V1), with at least one of the following subjective symptoms: ocular...
- Meeting one of the following criteria at the Screening Visit (Visit 1, V1): i. Positive corneal fluorescein staining, TBUT \< 10 s, and OSDI score ≥...
You likely can't join if
- people with current ocular herpes or any other ocular infection or inflammation, or a history of ocular herpes or any other ocular infection within...
- people with ocular diseases including structural abnormalities of the eyelid margin (ectropion, entropion, eyelid laxity, etc.), severe...
- people with secondary ocular scarring that, in the investigator's assessment, may affect subject compliance or outcome evaluation (e.g., radiation...
- people with secondary Sjögren's syndrome or other autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.), unless the...
- Not receiving steroids, immunomodulatory, or immunosuppressive agents for the disease;
- The investigator determines that the medical condition will not impact study results.
See the full eligibility criteria
- people who voluntarily participate and sign the informed consent form, are willing to comply with the treatment schedule specified in the study protocol, and attend follow-up visits on time.
- Aged ≥ 18 years, with no gender restriction.
- Best-corrected visual acuity (BCVA) of both eyes (OU) ≥ 0.1 at the Screening Visit (Visit 1, V1).
- History of dry eye disease in both eyes prior to the Screening Visit (Visit 1, V1), with at least one of the following subjective symptoms: ocular dryness, foreign body sensation, burning sensation, eye fatigue...
- Meeting one of the following criteria at the Screening Visit (Visit 1, V1): i. Positive corneal fluorescein staining, TBUT \< 10 s, and OSDI score ≥ 13; ii. Negative corneal fluorescein staining, TBUT \< 5 s, and OSDI...
- people with current ocular herpes or any other ocular infection or inflammation, or a history of ocular herpes or any other ocular infection within 30 days prior to screening.
- people with ocular diseases including structural abnormalities of the eyelid margin (ectropion, entropion, eyelid laxity, etc.), severe conjunctivochalasis, Salzmann nodular corneal degeneration, damaged conjunctival...
- people with secondary ocular scarring that, in the investigator's assessment, may affect subject compliance or outcome evaluation (e.g., radiation scars, chemical burns, Stevens-Johnson syndrome, cicatricial pemphigoid...
- people with secondary Sjögren's syndrome or other autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.), unless the subject meets all of the following conditions:
- Not receiving steroids, immunomodulatory, or immunosuppressive agents for the disease;
- The investigator determines that the medical condition will not impact study results.
- people with a history of organ or bone marrow transplantation.
- people who wore contact lenses within 30 days prior to screening.
- people who received physical therapy for dry eye within 30 days prior to screening, including eyelid scrubbing, meibomian gland expression, warm compresses, fuming, or IPL laser therapy for bilateral dry eye.
- people who received oral aspirin or aspirin-containing medications, or used NSAIDs (topical ocular or systemic), or drugs known to induce ocular dryness (e.g., anticholinergics, SSRIs, etc.) within 30 days before...
- people who used the following medications within the specified periods before dosing:
- Antihistamines (ocular or systemic) or any topical ophthalmic medications within 14 days before dosing;
- Artificial tears within 14 days before dosing;
- Steroids or mast cell stabilizers (ocular or systemic) within 30 days before dosing;
- Varenicline or diquafosol within 30 days before dosing;
- Topical ocular cyclosporine or tacrolimus within 6 weeks before dosing.
- people with punctal plugs implantation or a history of punctal cautery within 12 weeks prior to screening.
- people who used antiglaucoma medications within 3 months prior to screening, had non-laser glaucoma surgery, or underwent glaucoma laser surgery within 6 months prior to the screening visit.
- people who underwent Nd:YAG laser capsulotomy within 6 months prior to screening, or corneal refractive surgery (e.g., LASIK) within 12 months prior to screening.
- people with known allergy to fluorescein, multiple drug allergies, or severe allergic diseases.
- people with other poorly controlled clinical conditions, such as severe chronic infection, severe cardiopulmonary disease, uncontrolled hypertension (defined as systolic blood pressure ≥ 150 mmHg or diastolic blood...
- Female people with a positive pregnancy test or lactating people; female people of childbearing potential or male people whose partners are of childbearing potential who are unwilling to use contraception during the...
- people who participated in any other clinical trial of investigational drugs or devices within 30 days prior to screening.
- Any other conditions deemed by the investigator to make the subject ineligible for enrollment (e.g., depression, etc.).
The study team makes the final eligibility decision.
Where it's taking place
- Xiamen, China, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xiamen, China, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.