About this trial
This study aims to evaluate the effector function and expression of TIGIT and PD-1 on Tregs, as well as the Th2/Treg ratio, in patients with allergic conjunctivitis with and without desensitization therapy, compared to healthy controls.
Peripheral blood and tear samples will be collected once at enrollment. Treg and Th2 populations will be immunophenotyped, TIGIT and PD-1 expression assessed, and functional assays performed. Cytokine and antibody (IgE, IgG4) concentrations will be measured in serum and tears.
Results will be analyzed using descriptive statistics, Shapiro-Wilk test for distribution, t-tests or ANOVA for group comparisons, and correlation analyses for associations, with p\<0.05 considered significant. This study seeks to identify immunological markers associated with disease severity and treatment response, potentially informing future therapeutic strategies.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subjects aged between 5 and 30 years, of either sex.
Subjects with a confirmed diagnosis of allergic conjunctivitis.
Presence of active symptoms.
Positive skin tests.
Disqualifiers
Subjects who have had an infection within the two months prior to sample collection.
Patients with other active systemic allergic diseases (such as bronchial asthma, dermatitis, among others).
Subjects with chronic-degenerative or autoimmune diseases.
Subjects who have received topical immunosuppressive treatment in the last two months.
Trial population
The study subjects are patients recruited from the outpatient clinic of "Clinical Immunology" at Instituto de Oftalmologia Conde de Valenciana. All patients are evaluated by specialists in ophthalmology and allergy.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
To evaluate the effector function and the expression of TIGIT and PD-1 molecules on regulatory T cells, as well as the Th2/Treg, in patients with allergic conjunctivitis with and without allergen-specific immunotherapy, and in healthy control subjects.
Patients with allergic conjunctivitis, both with and without desensitization treatment, as well as healthy subjects as a control group, will be included in the study. Peripheral blood and tear samples will be collected from all participants. Peripheral blood samples will be used for immunophenotyping of Treg and Th2 lymphocytes and for assessing the expression levels of the effector molecules TIGIT and PD-1.
Proportion of Treg and Th2 lymphocytes and Th2/Treg ratio in peripheral blood
Peripheral blood mononuclear cells will be immunophenotyped to quantify Treg and Th2 populations and calculate the Th2/Treg ratio.
Cytokine profile associated with Treg and Th2 lymphocytes in serum and tears
Concentrations of cytokines related to Treg (e.g., IL-10) and Th2 (e.g., IL-4, IL-5, IL-13) will be measured in serum and tear samples.
Effector function of Treg lymphocytes assessed by TIGIT and PD-1 expression and functional assays.
Treg cells will be analyzed for expression of effector molecules TIGIT and PD-1, and functional assays will be performed to assess suppressive capacity.
Secondary outcomes
Concentration of IgE and IgG4 antibodies in serum and tears
Serum and tear samples will be analyzed to determine levels of IgE and IgG4 antibodies.
Correlation of immunological parameters with ocular symptom severity and treatment response
Associations between immunological markers (Treg/Th2 ratio, cytokine levels, IgE/IgG4 concentrations, TIGIT/PD-1 expression) and clinical outcomes will be evaluated.
Sponsors and contacts
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