Conjunctivitis, AllergicOJO-miRNCT07385495
OJO-miR: microRNA Expression in Allergic Conjunctivitis.
An observational study of Conjunctivitis, Allergic, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
Trial summary
Allergic conjunctivitis (AC) causes inflammation of the conjunctiva in response to environmental allergens, affecting a significant percentage of the world population and reducing quality of life. The pathophysiology is poorly understood, lacking effective treatments. 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
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 5 Jan 2026to 5 Jul 2027
- 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 population will include subjects aged 5 to 30 years with a clinical diagnosis of allergic conjunctivitis, as well as age-matched healthy controls. Participants will be recruited from a specialized ophthalmology center. Subjects with allergic conjunctivitis must present active ocular symptoms at the time of enrollment, while healthy controls must have a clinically normal ocular surface and no history of active ocular disease. All participants or their legal guardians will provide written informed consent, with assent obtained from minors when applicable.
Who may be able to join
- Subjects with Allergic Conjunctivitis:
- Age between 5 and 30 years.
- Clinical diagnosis of allergic conjunctivitis.
- Presence of active ocular symptoms at the time of sample collection.
- Positive skin prick test.
- Written informed consent signed by the participant or parent/legal guardian, -with assent when applicable.
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- Healthy Controls:
- Age between 5 and 30 years.
- Clinically healthy subjects with a normal ocular surface.
- No evidence of active ocular disease.
- Written informed consent signed by the participant or parent/legal guardian, with assent when applicable.
Who cannot join
- Subjects with Allergic Conjunctivitis:
- History of infectious disease within 2 months prior to sample collection.
- Presence of active systemic allergic diseases (e.g., asthma, active dermatitis).
- Chronic degenerative or autoimmune diseases.
- Use of topical immunosuppressive treatment within 2 months prior to sample collection.
- Use of systemic immunosuppressive therapy.
- Healthy Controls:
- -History of infectious disease within 2 months prior to sample collection.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto de Oftalmología FAP Conde de Valenciana, IAP Sede Centro
Mexico City, Mexico City, 06800
About this study
Official title: Analysis of the Expression Profiles of Inflammation-regulating microRNAs in Serum and Tear Samples From Subjects With Allergic Conjunctivitis.
Allergic conjunctivitis (AC) causes inflammation of the conjunctiva in response to environmental allergens, affecting a significant percentage of the world population and reducing quality of life. The pathophysiology is poorly understood, lacking effective treatments. MicroRNAs have potential for diagnosing and characterizing inflammatory diseases. This study aims to compare the expression profiles of inflammation-regulating microRNAs (miR-19, miR-23, miR-125b, miR-146a, and miR-155) in serum and tear samples from subjects with AC and healthy subjects to identify biomarkers and therapeutic targets.
Read the detailed description
Allergic conjunctivitis (AC) is an inflammatory disorder of the conjunctiva triggered by exposure to environmental allergens. This ocular condition affects a significant proportion of the global population, leading to a reduction in quality of life and, in some cases, visual impairment. The pathophysiology of AC remains poorly understood, and effective targeted therapies are limited. MicroRNAs have emerged as promising tools for the diagnosis and characterization of inflammatory diseases such as asthma and rhinitis; however, studies evaluating microRNA involvement in allergic conjunctivitis are scarce. Therefore, identifying microRNAs that are differentially regulated in AC is essential to better understand disease pathogenesis and to explore potential biomarkers and therapeutic targets.
This study aims to determine whether differences exist in the expression profiles of inflammation-regulatory microRNAs between subjects with allergic conjunctivitis and healthy controls. The working hypothesis is that subjects with allergic conjunctivitis exhibit differential expression of inflammation-related microRNAs compared with healthy individuals.
An observational cross-sectional study will be conducted including subjects aged 5 to 30 years with a clinical diagnosis of allergic conjunctivitis, as well as age-matched healthy controls. Tear samples and peripheral blood samples for serum isolation will be collected from all participants. Total RNA will be extracted from both sample types, and the expression of miR-19, miR-23, miR-125b, miR-146a, and miR-155 will be quantified using quantitative real-time polymerase chain reaction (qRT-PCR). Relative expression levels (fold change) will be calculated in the allergic conjunctivitis group and compared with those observed in healthy controls to identify microRNAs specifically associated with the disease. Receiver operating characteristic (ROC) curve analysis will be performed to evaluate the potential of the studied microRNAs as diagnostic biomarkers.
- Conditions
- Conjunctivitis, Allergic
- Keywords
- microRNA, Tears, Serum, Ocular Surface, inflammation
- Medical subject headings
- Conjunctivitis, Allergic, Lacerations, Inflammation
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 |
|---|---|---|
| Subjects with Allergic Conjunctivitis | Subjects aged 5 to 30 years with a confirmed clinical diagnosis of allergic conjunctivitis (Seasonal, Perennial, or Vernal Keratoconjunctivitis). Participants must present active symptomatology and positive skin prick tests corresponding to the allergic condition. | |
| Healthy Controls | Clinically healthy subjects aged 5 to 30 years with a normal ocular surface evaluation. Participants must have no personal history of allergic diseases (ocular or systemic), no active ocular infection, and no chronic-degenerative or autoimmune diseases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of inflammation-regulatory microRNAs in tear samples
Relative expression (fold change) of miR-19, miR-23, miR-125b, miR-146a, and miR-155 in tear samples measured by quantitative real-time polymerase chain reaction (qRT-PCR) and calculated using the 2^-ΔΔCT method.
Measured: Baseline
Expression of inflammation-regulatory microRNAs in serum samples
Relative expression (fold change) of miR-19, miR-23, miR-125b, miR-146a, and miR-155 in serum samples measured by quantitative real-time polymerase chain reaction (qRT-PCR) and calculated using the 2^-ΔΔCT method.
Measured: Baseline
Secondary outcomes (1)
Diagnostic performance of candidate microRNAs
Evaluation of the diagnostic potential of miR-19, miR-23, miR-125b, miR-146a, and miR-155 through receiver operating characteristic (ROC) curve analysis, including area under the curve (AUC).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start5 Jan 2026
- Primary completion5 Jan 2027 (estimated)
- Study completion5 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
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
- NCT07385495
- Sponsor's protocol ID
- CEI-2025/09/05
- Other IDs
- Research Committee, Biosecurity Committee
- Acronym
- OJO-miR
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Expression Profiles of Inflammation-regulating microRNAs in Serum and Tear Samples From Subjects With Allergic Conjunctivitis.
- ClinicalTrials.gov ID
- NCT07385495
- Acronym / sponsor ID
- OJO-miR / CEI-2025/09/05
- Conditions
- Conjunctivitis, Allergic
- Keywords
- microRNA, Tears, Serum, Ocular Surface, inflammation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de ValencianaUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 5 Jan 2027 (estimated)
- Study completion
- 5 Jul 2027 (estimated)
- First posted
- 4 Feb 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.
Allergic conjunctivitis (AC) causes inflammation of the conjunctiva in response to environmental allergens, affecting a significant percentage of the world population and reducing quality of life. The pathophysiology is poorly understood, lacking effective treatments. MicroRNAs have potential for diagnosing and characterizing inflammatory diseases. This study aims to compare the expression profiles of inflammation-regulating microRNAs (miR-19, miR-23, miR-125b, miR-146a, and miR-155) in serum and tear samples from subjects with AC and healthy subjects to identify biomarkers and therapeutic targets.
Detailed description
Allergic conjunctivitis (AC) is an inflammatory disorder of the conjunctiva triggered by exposure to environmental allergens. This ocular condition affects a significant proportion of the global population, leading to a reduction in quality of life and, in some cases, visual impairment. The pathophysiology of AC remains poorly understood, and effective targeted therapies are limited. MicroRNAs have emerged as promising tools for the diagnosis and characterization of inflammatory diseases such as asthma and rhinitis; however, studies evaluating microRNA involvement in allergic conjunctivitis are scarce. Therefore, identifying microRNAs that are differentially regulated in AC is essential to better understand disease pathogenesis and to explore potential biomarkers and therapeutic targets.
This study aims to determine whether differences exist in the expression profiles of inflammation-regulatory microRNAs between subjects with allergic conjunctivitis and healthy controls. The working hypothesis is that subjects with allergic conjunctivitis exhibit differential expression of inflammation-related microRNAs compared with healthy individuals.
An observational cross-sectional study will be conducted including subjects aged 5 to 30 years with a clinical diagnosis of allergic conjunctivitis, as well as age-matched healthy controls. Tear samples and peripheral blood samples for serum isolation will be collected from all participants. Total RNA will be extracted from both sample types, and the expression of miR-19, miR-23, miR-125b, miR-146a, and miR-155 will be quantified using quantitative real-time polymerase chain reaction (qRT-PCR). Relative expression levels (fold change) will be calculated in the allergic conjunctivitis group and compared with those observed in healthy controls to identify microRNAs specifically associated with the disease. Receiver operating characteristic (ROC) curve analysis will be performed to evaluate the potential of the studied microRNAs as diagnostic biomarkers.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with Allergic Conjunctivitis | – | –Subjects aged 5 to 30 years with a confirmed clinical diagnosis of allergic conjunctivitis (Seasonal, Perennial, or Vernal Keratoconjunctivitis). Participants must present active symptomatology and positive skin prick tests corresponding to the allergic condition. |
| Healthy Controls | – | –Clinically healthy subjects aged 5 to 30 years with a normal ocular surface evaluation. Participants must have no personal history of allergic diseases (ocular or systemic), no active ocular infection, and no chronic-degenerative or autoimmune diseases. |
Who may qualify
- Ages
- 5 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study population will include subjects aged 5 to 30 years with a clinical diagnosis of allergic conjunctivitis, as well as age-matched healthy controls. Participants will be recruited from a specialized ophthalmology center. Subjects with allergic conjunctivitis must present active ocular symptoms at the time of enrollment, while healthy controls must have a clinically normal ocular surface and no history of active ocular disease. All participants or their legal guardians will provide written informed consent, with assent obtained from minors when applicable.
Key inclusion criteria (11 listed)
- Subjects with Allergic Conjunctivitis:
- Age between 5 and 30 years.
- Clinical diagnosis of allergic conjunctivitis.
- Presence of active ocular symptoms at the time of sample collection.
- Positive skin prick test.
Key exclusion criteria (8 listed)
- Subjects with Allergic Conjunctivitis:
- History of infectious disease within 2 months prior to sample collection.
- Presence of active systemic allergic diseases (e.g., asthma, active dermatitis).
- Chronic degenerative or autoimmune diseases.
- Use of topical immunosuppressive treatment within 2 months prior to sample collection.
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
Expression of inflammation-regulatory microRNAs in tear samples
Time frame: Baseline
Relative expression (fold change) of miR-19, miR-23, miR-125b, miR-146a, and miR-155 in tear samples measured by quantitative real-time polymerase chain reaction (qRT-PCR) and calculated using the 2^-ΔΔCT method.
Expression of inflammation-regulatory microRNAs in serum samples
Time frame: Baseline
Relative expression (fold change) of miR-19, miR-23, miR-125b, miR-146a, and miR-155 in serum samples measured by quantitative real-time polymerase chain reaction (qRT-PCR) and calculated using the 2^-ΔΔCT method.
1 secondary outcome
Diagnostic performance of candidate microRNAs
Time frame: Baseline
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 4 Feb 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 11 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 4 Feb 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of inflammation-regulatory microRNAs in tear samples (time frame: Baseline). 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?
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 4 Feb 2026.