Conjunctivitis, AllergicINMUNOREGNCT07171307
Treg Effector Function and Th2/Treg Ratio in Allergic Conjunctivitis: Effect of Desensitization Therapy
An observational study of Conjunctivitis, Allergic, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Conjunctivitis, Allergic
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jan 2026to Sep 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 5 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study 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.
Who may be able to join
- 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.
- Willingness to participate in the protocol by signing informed consent.
Who cannot join
- 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.
- Subjects receiving systemic immunosuppressive therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Instituto de Oftalmología FAP Conde de Valenciana, IAP Sede Centro
Mexico City, Mexico City, 06800
About this study
Official title: Study of the Effector Function of Regulatory T Cells and the Th2/Treg in Patients With Allergic Conjunctivitis With and Without Desensitization Treatment
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.
Read the detailed description
Allergic conjunctivitis is a prevalent ocular condition affecting approximately 10-20% of the global population, with 40-60% of allergic individuals exhibiting ocular symptoms. It is characterized by redness, itching, burning, and tearing, which result from excessive activation of immune response cells. Severe forms can significantly impact vision and quality of life, particularly in children, adolescents, and young adults. The disease is mediated by hypersensitivity reactions: Th2 lymphocytes release cytokines (IL-4, IL-5, IL-13) that stimulate IgE production by B lymphocytes. IgE binds to mast cells and induces the release of pro-inflammatory mediators upon allergen recognition. Regulatory T cells (Tregs) play a critical role in maintaining immune homeostasis by suppressing the activation and proliferation of effector T cell subsets, including Th1, Th2, Th9, and Th17, via cell-surface molecules such as TIGIT, LAP-TGF-β, and PD-1. Additionally, Tregs produce IL-10, which suppresses IgE production and induces IgG4 secretion by B cells. Allergen-specific immunotherapy (desensitization) has been employed to reduce symptoms and prevent recurrence in allergic diseases.
Rationale:
Allergic conjunctivitis is a public health concern that affects the quality of life of a substantial portion of the Mexican population. Immunological imbalances between effector T cells and Tregs have been reported. Understanding the balance of these subpopulations and the role of TIGIT and PD-1 molecules in Treg functional status is critical to elucidating disease mechanisms. Moreover, it is important to determine whether desensitization therapy induces changes in the Th2/Treg ratio and modulates TIGIT and PD-1 expression, which could serve as biomarkers of treatment response or therapeutic targets.
Hypothesis:
The effector function and expression of TIGIT and PD-1 on Tregs are decreased in patients with allergic conjunctivitis and are enhanced following desensitization therapy.
Objectives:
The primary objective is to evaluate the effector function and expression of TIGIT and PD-1 on Tregs and the Th2/Treg ratio in patients with allergic conjunctivitis with and without desensitization therapy, compared to healthy controls. Secondary objectives include assessing correlations between immunological parameters and clinical severity of ocular symptoms and response to treatment.
Study Design and Methods:
This observational, cross-sectional, case-control study will include patients with allergic conjunctivitis, with or without desensitization therapy, and healthy control subjects. Peripheral blood and tear samples will be collected once at enrollment. Peripheral blood mononuclear cells will undergo immunophenotyping to quantify Treg and Th2 populations and assess TIGIT and PD-1 expression. Tregs will be isolated for functional assays. Cytokine concentrations associated with Th2 and Treg cells, as well as IgE and IgG4 levels, will be measured in serum and tears.
Statistical Analysis:
Descriptive statistics will summarize participant characteristics and study outcomes. The Shapiro-Wilk test will assess data distribution. Comparisons between two groups will use t-tests (parametric or non-parametric), and comparisons among more than two groups will use ANOVA (parametric or non-parametric). Correlation analyses will evaluate associations between immunological parameters and clinical outcomes. A p-value <0.05 will be considered statistically significant.
- Conditions
- Conjunctivitis, Allergic
- Keywords
- conjunctivitis allergic, TIGIT, Tregs, PDL-1
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Conjunctivitis Allergic with allergen-specific immunotherapy (AIT) | The study subjects will be patients with a confirmed diagnosis of allergic conjunctivitis, active symptoms, and positive skin tests, who do not present any other type of systemic or local disease or inflammatory process and who are receiving allergen-specific immunotherapy (AIT). | |
| Conjunctivitis Allergic without allergen-specific immunotherapy (AIT) | The study subjects will be patients with a confirmed diagnosis of allergic conjunctivitis, active symptoms, and positive skin tests, who do not present any other type of systemic or local disease or inflammatory process, and who are not receiving immunotherapy treatment. | |
| Control group | The control subjects will be clinically healthy individuals, with a normal ocular surface and no evidence of active ocular disease or local or systemic inflammatory or infectious processes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline (single assessment at enrollment in all study and control groups)
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.
Measured: At baseline (single assessment at enrollment in all study and control groups)
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.
Measured: At baseline (single assessment at enrollment in all study and control groups)
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.
Measured: At baseline (single assessment at enrollment in all study and control groups)
Secondary outcomes (2)
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.
Measured: At baseline (single assessment at enrollment in all study and control groups)
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.
Measured: At enrollment (clinical evaluation performed once in all study and control groups)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start1 Jan 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Conjunctivitis, AllergicStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María C. Jiménez Martínez, Instituto de Oftalmología Fundación Conde de Valenciana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171307
- Sponsor's protocol ID
- CEI-2024/06/16
- Other IDs
- CI-032-2024, CB-031-2024
- Acronym
- INMUNOREG
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kucuksezer UC, Ozdemir C, Cevhertas L, Ogulur I, Akdis M, Akdis CA. Mechanisms of allergen-specific immunotherapy and allergen tolerance. Allergol Int. 2020 Oct;69(4):549-560. doi: 10.1016/j.alit.2020.08.002. Epub 2020 Sep 6.
PubMed 32900655Calzada D, Baos S, Cremades-Jimeno L, Cardaba B. Immunological Mechanisms in Allergic Diseases and Allergen Tolerance: The Role of Treg Cells. J Immunol Res. 2018 Jun 14;2018:6012053. doi: 10.1155/2018/6012053. eCollection 2018.
PubMed 30013991
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effector Function of Regulatory T Cells and the Th2/Treg in Patients With Allergic Conjunctivitis With and Without Desensitization Treatment
- ClinicalTrials.gov ID
- NCT07171307
- Acronym / sponsor ID
- INMUNOREG / CEI-2024/06/16
- Conditions
- Conjunctivitis, Allergic
- Keywords
- conjunctivitis allergic, TIGIT, Tregs, PDL-1
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de ValencianaUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 12 Sep 2025 (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.
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.
Detailed description
Allergic conjunctivitis is a prevalent ocular condition affecting approximately 10-20% of the global population, with 40-60% of allergic individuals exhibiting ocular symptoms. It is characterized by redness, itching, burning, and tearing, which result from excessive activation of immune response cells. Severe forms can significantly impact vision and quality of life, particularly in children, adolescents, and young adults. The disease is mediated by hypersensitivity reactions: Th2 lymphocytes release cytokines (IL-4, IL-5, IL-13) that stimulate IgE production by B lymphocytes. IgE binds to mast cells and induces the release of pro-inflammatory mediators upon allergen recognition. Regulatory T cells (Tregs) play a critical role in maintaining immune homeostasis by suppressing the activation and proliferation of effector T cell subsets, including Th1, Th2, Th9, and Th17, via cell-surface molecules such as TIGIT, LAP-TGF-β, and PD-1. Additionally, Tregs produce IL-10, which suppresses IgE production and induces IgG4 secretion by B cells. Allergen-specific immunotherapy (desensitization) has been employed to reduce symptoms and prevent recurrence in allergic diseases.
Rationale:
Allergic conjunctivitis is a public health concern that affects the quality of life of a substantial portion of the Mexican population. Immunological imbalances between effector T cells and Tregs have been reported. Understanding the balance of these subpopulations and the role of TIGIT and PD-1 molecules in Treg functional status is critical to elucidating disease mechanisms. Moreover, it is important to determine whether desensitization therapy induces changes in the Th2/Treg ratio and modulates TIGIT and PD-1 expression, which could serve as biomarkers of treatment response or therapeutic targets.
Hypothesis:
The effector function and expression of TIGIT and PD-1 on Tregs are decreased in patients with allergic conjunctivitis and are enhanced following desensitization therapy.
Objectives:
The primary objective is to evaluate the effector function and expression of TIGIT and PD-1 on Tregs and the Th2/Treg ratio in patients with allergic conjunctivitis with and without desensitization therapy, compared to healthy controls. Secondary objectives include assessing correlations between immunological parameters and clinical severity of ocular symptoms and response to treatment.
Study Design and Methods:
This observational, cross-sectional, case-control study will include patients with allergic conjunctivitis, with or without desensitization therapy, and healthy control subjects. Peripheral blood and tear samples will be collected once at enrollment. Peripheral blood mononuclear cells will undergo immunophenotyping to quantify Treg and Th2 populations and assess TIGIT and PD-1 expression. Tregs will be isolated for functional assays. Cytokine concentrations associated with Th2 and Treg cells, as well as IgE and IgG4 levels, will be measured in serum and tears.
Statistical Analysis:
Descriptive statistics will summarize participant characteristics and study outcomes. The Shapiro-Wilk test will assess data distribution. Comparisons between two groups will use t-tests (parametric or non-parametric), and comparisons among more than two groups will use ANOVA (parametric or non-parametric). Correlation analyses will evaluate associations between immunological parameters and clinical outcomes. A p-value <0.05 will be considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conjunctivitis Allergic with allergen-specific immunotherapy (AIT) | – | –The study subjects will be patients with a confirmed diagnosis of allergic conjunctivitis, active symptoms, and positive skin tests, who do not present any other type of systemic or local disease or inflammatory process and who are receiving allergen-specific immunotherapy (AIT). |
| Conjunctivitis Allergic without allergen-specific immunotherapy (AIT) | – | –The study subjects will be patients with a confirmed diagnosis of allergic conjunctivitis, active symptoms, and positive skin tests, who do not present any other type of systemic or local disease or inflammatory process, and who are not receiving immunotherapy treatment. |
| Control group | – | –The control subjects will be clinically healthy individuals, with a normal ocular surface and no evidence of active ocular disease or local or systemic inflammatory or infectious processes. |
Who may qualify
- Ages
- 5 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study 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.
Key inclusion criteria (5 listed)
- 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.
- Willingness to participate in the protocol by signing informed consent.
Key exclusion criteria (5 listed)
- 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.
- Subjects receiving systemic immunosuppressive therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: At baseline (single assessment at enrollment in all study and control groups)
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
Time frame: At baseline (single assessment at enrollment in all study and control groups)
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
Time frame: At baseline (single assessment at enrollment in all study and control groups)
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.
Time frame: At baseline (single assessment at enrollment in all study and control groups)
Treg cells will be analyzed for expression of effector molecules TIGIT and PD-1, and functional assays will be performed to assess suppressive capacity.
2 secondary outcomes
Concentration of IgE and IgG4 antibodies in serum and tears
Time frame: At baseline (single assessment at enrollment in all study and control groups)
Correlation of immunological parameters with ocular symptom severity and treatment response
Time frame: At enrollment (clinical evaluation performed once in all study and control groups)
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 17 Sep 2025.
- Background: PubMed 32900655Kucuksezer UC, Ozdemir C, Cevhertas L, Ogulur I, Akdis M, Akdis CA. Mechanisms of allergen-specific immunotherapy and allergen tolerance. Allergol Int. 2020 Oct;69(4):549-560. doi: 10.1016/j.alit.2020.08.002. Epub 2020 Sep 6.
- Background: PubMed 30013991Calzada D, Baos S, Cremades-Jimeno L, Cardaba B. Immunological Mechanisms in Allergic Diseases and Allergen Tolerance: The Role of Treg Cells. J Immunol Res. 2018 Jun 14;2018:6012053. doi: 10.1155/2018/6012053. eCollection 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Conjunctivitis, Allergic, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
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 5 inclusion and 5 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 17 Sep 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 Mexico. 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.
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 María del Carmén Jiménez Martínez (5554421700, mcjimenezm@institutodeoftalmologia.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: At baseline (single assessment at enrollment in all study and control groups)). The study lists 4 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 NCT07171307, which also lists 2 linked publications.
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 17 Sep 2025.