KeratitisPhase 1NCT07902687
A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
A Phase 1 study testing MSCohi-O lens in people with Keratitis and Autoimmunity, run by Guangdong ProCapZoom Biosciences Co., Ltd..
Trial summary
Immune-related ocular surface diseases are a kind of non-infectious eye disease pedigree, which is mediated by abnormal immune system function and characterized by ocular surface tissue damage. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Keratitis, Autoimmunity, Dry Eye Disease (DED)
- What is being tested?
- MSCohi-O lens
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 30 Nov 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 ~ 65 years old (inclusive), regardless of gender;
- Patients diagnosed as immune-related ocular surface diseases;
- The symptoms of eye involvement cannot be relieved or poorly controlled after at least three months of traditional treatment (including the use of artificial tears, glucocorticoid, immunosuppressants, etc.);
- Systemic immune diseases (if applicable) are in a stable stage;
- Karnofsky functional status score (KPS score) > 60 ;
- The functions of important organs meet the following requirements: the absolute neutrophil count is ≥ 1.0× 10^9/L; Platelets ≥ 75× 10^9/L; Hemoglobin ≥ 10g/dl; Bilirubin ≤1.5 times ULN； ALT and AST≤3 times ULN；Serum creatinine ≤1.5 times ULN；
- All the subjects and their partners had no birth plan within 6 months from the screening to the last administration and agreed to take effective non-drug contraceptive measures during the trial;
- voluntarily participate in the research, understand and sign the informed consent.
Who cannot join
- those who are allergic to any component of the experimental drug;
- The subject suffers from any unstable or uncontrolled cardiovascular, pulmonary, gastrointestinal, urogenital, blood coagulation, immunology, endocrine, metabolism or other medical diseases, and the researcher judges that it will interfere with the research results or endanger the safety of the subject;
- Other eye diseases during screening:
- Other eye diseases unrelated to immune-related ocular surface diseases; Acute active fungal, bacterial or viral keratitis or conjunctivitis and other acute eye infections; Glaucoma or cataract, or other eye diseases, which the researcher evaluates may affect the efficacy and safety evaluation.
- Have used any anti-VEGF drugs on the ocular surface within 30 days before joining the group;
- Those who have received any eye surgery within 3 months before screening; Ophthalmic interventions that have been completely healed before admission and the researcher's judgment does not affect the research evaluation are allowed, such as cataract surgery ≥3 months and stable.
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- Patients who have a history of wearing contact lenses and cannot be removed during treatment;
- Those who have mental disorder or cognitive disorder and cannot meet the requirements of the research plan;
- Those who have participated in clinical trials of other new drugs within 3 months before screening;
- The researcher believes that there is a history of systemic diseases or mental illness that may increase the risk of the subjects or affect the evaluation of the research results;
- those who have tested positive for anti-HIV antibody or anti-Treponema pallidum specific antibody during the screening period; Or hepatitis C antibody positive, hepatitis C virus RNA positive, hepatitis B surface antigen positive, or hepatitis B core antibody positive in patients with a past history of hepatitis B, and accompanied by HBV-DNA ≥ 2000 IU/ml in recent 3 months;
- Patients with malignant solid tumors in the past, except for the following cases: cured stage IB or lower cervical cancer, non-invasive basal cell or squamous cell skin cancer, malignant melanoma with complete remission (CR) of more than 10 years, and other malignant tumors with complete remission (CR) of more than 5 years;
- pregnant or lactating women, or those who are positive in blood pregnancy test during screening;
- The researcher thinks that it is not suitable to enter this experiment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Immune-related ocular surface diseases are a kind of non-infectious eye disease pedigree, which is mediated by abnormal immune system function and characterized by ocular surface tissue damage. It mainly covers immune keratitis, immune disease-related dry eye, allergic keratoconjunctivitis, Thygeson superficial punctate keratitis, mucosal pemphigoid-related ocular surface damage and other clinical types, and its incidence is closely related to autoimmune disorder, abnormal immune response after infection, genetic susceptibility and environmental triggering factors.
At present, there are still obvious therapeutic limitations in clinical routine treatment for immune-related ocular surface diseases. The first-line treatment plan mainly focuses on local glucocorticoid and non-steroidal anti-inflammatory drugs to inhibit inflammatory reaction. Although it can quickly control corneal edema and infiltration in acute stage, there are serious adverse reactions such as elevated intraocular pressure, cataract and corneal thinning and perforation after long-term use, which cannot meet the needs of long-term maintenance treatment.
Read more
Umbilical cord mesenchymal stem cells (UCMSC) have unique immunomodulatory characteristics in inflammatory environment. Its mechanism of action is mainly to inhibit the over-activation of immune cells and reduce the content of pro-inflammatory factors by secreting soluble cytokines and regulating the release of various anti-inflammatory factors. However, under the traditional medication mode, UCMSC can not stay on the ocular surface. Our company has developed a medicine, namely MSCohi-O lens, which uses soft hydrophilic contact lens to load UCMSC, so as to realize long-term local administration on the ocular surface, make UCMSC play an immunomodulatory role locally, inhibit the over-activation of immune/inflammatory reaction, and finally treat or alleviate the symptoms of immune-related ocular surface diseases.
This clinical study is expected to explore the clinical effect of MSCohi-O lens in the treatment of immune-related ocular surface diseases, and initially determine the clinical application of MSCohi-O lens in the treatment of immune-related ocular surface diseases, so as to provide new clinical schemes and treatment ideas for the treatment of immune-related ocular surface diseases.
- Conditions
- Keratitis, Autoimmunity, Dry Eye Disease (DED)
- Being tested
- MSCohi-O lens
- Medical subject headings
- Keratitis, Autoimmune Diseases, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSCohi-O lensDrug
Each subject chooses one eye as the research eye (if both eyes are consistent, the one with higher corneal fluorescein staining score is preferred, and the eye with poor vision is selected when the score is consistent). The time of wearing glasses is 10 hours a day, wearing them at 08:00 am and taking them off at 18:00 pm.
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | Wear MSCohi-O lenses once a day for 10 hours each time, for a total of 6 times. Receives: Drug: MSCohi-O lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of adverse events within 29 days after the first administration were calculated.
Measured: 29 days
Secondary outcomes (5)
Incidence and severity of adverse events during the trial.
Measured: 29 days
Changes of corneal fluorescein staining score from baseline on the 7 th, 15 th and 29 th day after the first administration.
Measured: 29 days
Changes of ocular surface disease index score (OSDI) from baseline on the 7th, 15th and 29th day after the first administration.
Measured: 29 days
Changes of tear secretion test from baseline on the 7 th, 15 th and 29 th day after the first administration.
Measured: 29 days
Changes of tear osmotic pressure from baseline on the 7 th, 15 th and 29 th day after the first administration.
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong ProCapZoom Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902687
- Sponsor's protocol ID
- PLKR-SZ018-IOSD-IIT-001
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
- ClinicalTrials.gov ID
- NCT07902687
- Acronym / sponsor ID
- PLKR-SZ018-IOSD-IIT-001
- Conditions
- Keratitis, Autoimmunity, Dry Eye Disease (DED)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Guangdong ProCapZoom Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Immune-related ocular surface diseases are a kind of non-infectious eye disease pedigree, which is mediated by abnormal immune system function and characterized by ocular surface tissue damage. It mainly covers immune keratitis, immune disease-related dry eye, allergic keratoconjunctivitis, Thygeson superficial punctate keratitis, mucosal pemphigoid-related ocular surface damage and other clinical types, and its incidence is closely related to autoimmune disorder, abnormal immune response after infection, genetic susceptibility and environmental triggering factors.
At present, there are still obvious therapeutic limitations in clinical routine treatment for immune-related ocular surface diseases. The first-line treatment plan mainly focuses on local glucocorticoid and non-steroidal anti-inflammatory drugs to inhibit inflammatory reaction. Although it can quickly control corneal edema and infiltration in acute stage, there are serious adverse reactions such as elevated intraocular pressure, cataract and corneal thinning and perforation after long-term use, which cannot meet the needs of long-term maintenance treatment.
Umbilical cord mesenchymal stem cells (UCMSC) have unique immunomodulatory characteristics in inflammatory environment. Its mechanism of action is mainly to inhibit the over-activation of immune cells and reduce the content of pro-inflammatory factors by secreting soluble cytokines and regulating the release of various anti-inflammatory factors. However, under the traditional medication mode, UCMSC can not stay on the ocular surface. Our company has developed a medicine, namely MSCohi-O lens, which uses soft hydrophilic contact lens to load UCMSC, so as to realize long-term local administration on the ocular surface, make UCMSC play an immunomodulatory role locally, inhibit the over-activation of immune/inflammatory reaction, and finally treat or alleviate the symptoms of immune-related ocular surface diseases.
This clinical study is expected to explore the clinical effect of MSCohi-O lens in the treatment of immune-related ocular surface diseases, and initially determine the clinical application of MSCohi-O lens in the treatment of immune-related ocular surface diseases, so as to provide new clinical schemes and treatment ideas for the treatment of immune-related ocular surface diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Drug: MSCohi-O lensWear MSCohi-O lenses once a day for 10 hours each time, for a total of 6 times. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 ~ 65 years old (inclusive), regardless of gender;
- Patients diagnosed as immune-related ocular surface diseases;
- The symptoms of eye involvement cannot be relieved or poorly controlled after at least three months of traditional treatment (including the use of artificial tears, glucocorticoid, immunosuppressants, etc.);
- Systemic immune diseases (if applicable) are in a stable stage;
- Karnofsky functional status score (KPS score) > 60 ;
Key exclusion criteria (14 listed)
- those who are allergic to any component of the experimental drug;
- The subject suffers from any unstable or uncontrolled cardiovascular, pulmonary, gastrointestinal, urogenital, blood coagulation, immunology, endocrine, metabolism or other medical diseases, and the researcher judges that it will interfere with the research results or endanger the safety of the subject;
- Other eye diseases during screening:
- Other eye diseases unrelated to immune-related ocular surface diseases; Acute active fungal, bacterial or viral keratitis or conjunctivitis and other acute eye infections; Glaucoma or cataract, or other eye diseases, which the researcher evaluates may affect the efficacy and safety evaluation.
- Have used any anti-VEGF drugs on the ocular surface within 30 days before joining the group;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSCohi-O lensEach subject chooses one eye as the research eye (if both eyes are consistent, the one with higher corneal fluorescein staining score is preferred, and the eye with poor vision is selected when the score is consistent). The time of wearing glasses is 10 hours a day, wearing them at 08:00 am and taking them off at 18:00 pm. | Drug | group A |
Primary outcome
The incidence and severity of adverse events within 29 days after the first administration were calculated.
Time frame: 29 days
5 secondary outcomes
Incidence and severity of adverse events during the trial.
Time frame: 29 days
Changes of corneal fluorescein staining score from baseline on the 7 th, 15 th and 29 th day after the first administration.
Time frame: 29 days
Changes of ocular surface disease index score (OSDI) from baseline on the 7th, 15th and 29th day after the first administration.
Time frame: 29 days
Changes of tear secretion test from baseline on the 7 th, 15 th and 29 th day after the first administration.
Time frame: 29 days
Changes of tear osmotic pressure from baseline on the 7 th, 15 th and 29 th day after the first administration.
Time frame: 29 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MSCohi-O lens in people with Keratitis and Autoimmunity, run by Guangdong ProCapZoom Biosciences Co., Ltd..
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 8 inclusion and 14 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: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiexing Chen (86-18302002029, jxchen@procapzoom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of adverse events within 29 days after the first administration were calculated. (time frame: 29 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2026.