Clinical trial NCT06543667: Limbal Stem Cell Derived Exosome (LSC-Exo) Eye Drop for Treatment of Dry Eye
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Dry Eye Syndromes
Keywords: Dry Eye Disease
Sjogren's Syndrome
Chronic Dry Eye
Lead sponsor: Iran University of Medical Sciences
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

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\&#39;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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Inflammatory and Pro-inflammatory cytokines changes
timeFrame: 12 weeks
measure: Change in Ocular Surface Disease Index (OSDI)
timeFrame: 4, 8 , and 12 weeks
Secondary outcomes:
measure: Tear Secretion Test (Schirmer test)
timeFrame: 4, 8 , and 12 weeks
measure: Tear Film Break-up Time
timeFrame: 4, 8 , and 12 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Moheb Kowsar Hospital
Study officials:
References: