Dry Eye SyndromesPhase 1EXOIUMSNCT06543667
Limbal Stem Cell Derived Exosome (LSC-Exo) Eye Drop for Treatment of Dry Eye
A Phase 1 study testing Limbal Stem Cell Derived Exosomes Eye Drop in people with Dry Eye Syndromes, run by Iran University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine the safety and efficacy of Limbal Stem Cells derived Exosomes (LSC-Exo) in alleviation of dry eye symptoms Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Limbal Stem Cell Derived Exosomes Eye Drop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- 1 Aug 2024to 1 Jul 2026
- Phase
- Phase 1
- 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
- Patients with complaints of burning or itching or feeling of a foreign body in the eye
- Moderate and severe dry eye severity
- Age between 18-70 years
Who cannot join
- Previous history of eye surgery
- Any disease that suppresses the immune system
- Pregnancy and breastfeeding
- Eyelid abnormalities
- Use of eye drops in the past year except artificial tears and lubricating ointments
- Use of systemic drugs that affect the tear film in last three months
- Use of contact lenses in the last three months
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Moheb Kowsar Hospital
Tehran
Kian Alirezaei, MD, +989034561467, Kian.alirezaei.72@gmail.com
About this study
Official title: A Clinical Study for Safety and Efficacy Evaluation of Limbal Stem Cell Derived Exosome (LSC-Exo) Eye Drop for Treatment of Dry Eye Syndrome
The purpose of this study is to determine the safety and efficacy of Limbal Stem Cells derived Exosomes (LSC-Exo) in alleviation of dry eye symptoms
Read the detailed description
Dry eye is among the most prevalent chronic conditions in ophthalmology, significantly impacting quality of life and presenting a public health challenge that cannot be overlooked. Current treatment options primarily consist of artificial tear replacement, anti-inflammatory therapies, and local immunosuppressive treatments, which mainly focus on alleviating discomfort and other symptoms associated with the ocular surface. However, with the rapid advancements in regenerative medicine, ophthalmologists are exploring innovative approaches to treat dry eye. Chronic dry eye can result in corneal damage and potential vision loss. Recent studies suggest that therapeutic exosomes delivered as eye drops can enhance the immune microenvironment of the cornea and alter the ocular surface\'s microenvironment for better outcomes.
Exosomes are membrane vesicles secreted by parental cells, which can mediate the transfer of RNA, protein, DNA and other functional molecules of the parent cell between other cells and regulate the function of target cells. The therapeutic potential of Limbal Stem Cell Exosomes has been studied by our department. We found that LSC-Exo can alleviate the symptoms of dry eye in the animal study. At present, we plan to clarify its efficacy in a clinical research.
The main objective of this study is to evaluate the alleviation of Dry Eye symptoms in patients which are resist to conventional treatment by tear drops. The assessment will be done after LSC-Exo treatment by measuring Ocular Surface Index Score (OSDI), and the second objective include the measurement of inflammatory and pro-inflammatory cytokines in tear of patients, tear secretion amount, tear break time, the areas stained by fluorescent, ocular redness, tear meniscus and best corrected visual acuity.
Approximately 30 patients will be recruited. The treatment group will receive artificial tears for 2 weeks to normalize the baseline, followed by intervention of LSC-Exo 10ug/drop, four times a day for 30 days. The follow-up visit will be 12-weeks and the progression of dry eye will be measured.
- Conditions
- Dry Eye Syndromes
- Being tested
- Limbal Stem Cell Derived Exosomes Eye Drop
- Keywords
- Dry Eye Disease, Sjogren's Syndrome, Chronic Dry Eye
- Medical subject headings
- Dry Eye Syndromes, Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limbal Stem Cell Derived Exosomes Eye DropBiological
Patients will receive artificial tears for 2 weeks to get the normalized baseline, followed by LSC-Exo eye drops 0.15 ml/single eye/one time, four times a day for 3 months. The follow-up visit will be 12 weeks since the administration of LSC-Exo eye drops.
| Study group | Role | What they receive |
|---|---|---|
| Limbal Stem Cell Derived Exosome Eye Drop treatment | Experimental | Patients will receive artificial tears for 2 weeks to get the normalized baseline, followed by LSC-Exo eye drop intervention for 3 months. Receives: Biological: Limbal Stem Cell Derived Exosomes Eye Drop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Inflammatory and Pro-inflammatory cytokines changes
Dry eye is characterized by ocular surface inflammation. Proinflammatory cytokines IL-1, IL-6, IL-8, TNF-α and IFN-γ are strongly correlated with dry eye markers, leading to ocular surface damage.
Measured: 12 weeks
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: 4, 8 , and 12 weeks
Secondary outcomes (2)
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: 4, 8 , and 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.
Measured: 4, 8 , and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Aug 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromesStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alireza Shoae Hassani, Iran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543667
- Sponsor's protocol ID
- IRCT20231022059814N1
- Other IDs
- 1358-06
- Acronym
- EXOIUMS
- Status last verified
- Aug 2024
- First submitted
- 4 Aug 2024
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study for Safety and Efficacy Evaluation of Limbal Stem Cell Derived Exosome (LSC-Exo) Eye Drop for Treatment of Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT06543667
- Acronym / sponsor ID
- EXOIUMS / IRCT20231022059814N1
- Conditions
- Dry Eye Syndromes
- Keywords
- Dry Eye Disease, Sjogren's Syndrome, Chronic Dry Eye
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Iran University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 9 Aug 2024 (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.
The purpose of this study is to determine the safety and efficacy of Limbal Stem Cells derived Exosomes (LSC-Exo) in alleviation of dry eye symptoms
Detailed description
Dry eye is among the most prevalent chronic conditions in ophthalmology, significantly impacting quality of life and presenting a public health challenge that cannot be overlooked. Current treatment options primarily consist of artificial tear replacement, anti-inflammatory therapies, and local immunosuppressive treatments, which mainly focus on alleviating discomfort and other symptoms associated with the ocular surface. However, with the rapid advancements in regenerative medicine, ophthalmologists are exploring innovative approaches to treat dry eye. Chronic dry eye can result in corneal damage and potential vision loss. Recent studies suggest that therapeutic exosomes delivered as eye drops can enhance the immune microenvironment of the cornea and alter the ocular surface\'s microenvironment for better outcomes.
Exosomes are membrane vesicles secreted by parental cells, which can mediate the transfer of RNA, protein, DNA and other functional molecules of the parent cell between other cells and regulate the function of target cells. The therapeutic potential of Limbal Stem Cell Exosomes has been studied by our department. We found that LSC-Exo can alleviate the symptoms of dry eye in the animal study. At present, we plan to clarify its efficacy in a clinical research.
The main objective of this study is to evaluate the alleviation of Dry Eye symptoms in patients which are resist to conventional treatment by tear drops. The assessment will be done after LSC-Exo treatment by measuring Ocular Surface Index Score (OSDI), and the second objective include the measurement of inflammatory and pro-inflammatory cytokines in tear of patients, tear secretion amount, tear break time, the areas stained by fluorescent, ocular redness, tear meniscus and best corrected visual acuity.
Approximately 30 patients will be recruited. The treatment group will receive artificial tears for 2 weeks to normalize the baseline, followed by intervention of LSC-Exo 10ug/drop, four times a day for 30 days. The follow-up visit will be 12-weeks and the progression of dry eye will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Limbal Stem Cell Derived Exosome Eye Drop treatment | Experimental | Biological: Limbal Stem Cell Derived Exosomes Eye DropPatients will receive artificial tears for 2 weeks to get the normalized baseline, followed by LSC-Exo eye drop intervention for 3 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with complaints of burning or itching or feeling of a foreign body in the eye
- Moderate and severe dry eye severity
- Age between 18-70 years
Key exclusion criteria (7 listed)
- Previous history of eye surgery
- Any disease that suppresses the immune system
- Pregnancy and breastfeeding
- Eyelid abnormalities
- Use of eye drops in the past year except artificial tears and lubricating ointments
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 |
|---|---|---|
| Limbal Stem Cell Derived Exosomes Eye DropPatients will receive artificial tears for 2 weeks to get the normalized baseline, followed by LSC-Exo eye drops 0.15 ml/single eye/one time, four times a day for 3 months. The follow-up visit will be 12 weeks since the administration of LSC-Exo eye drops. | Biological | Limbal Stem Cell Derived Exosome Eye Drop treatment |
Primary outcome
Change in Inflammatory and Pro-inflammatory cytokines changes
Time frame: 12 weeks
Dry eye is characterized by ocular surface inflammation. Proinflammatory cytokines IL-1, IL-6, IL-8, TNF-α and IFN-γ are strongly correlated with dry eye markers, leading to ocular surface damage.
Change in Ocular Surface Disease Index (OSDI)
Time frame: 4, 8 , and 12 weeks
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
2 secondary outcomes
Tear Secretion Test (Schirmer test)
Time frame: 4, 8 , and 12 weeks
Tear Film Break-up Time
Time frame: 4, 8 , and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Derived from this study: PubMed 39839752Randall 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.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Limbal Stem Cell Derived Exosomes Eye Drop in people with Dry Eye Syndromes, run by Iran University of Medical Sciences at 1 site in Iran.
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 3 inclusion and 7 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 1 May 2025. 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 Iran. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hossein Aghaei, MD (+982155661188, draghaei.h@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Inflammatory and Pro-inflammatory cytokines changes (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT06543667, 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 1 May 2025.