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OJO-miR: microRNA Expression in Allergic Conjunctivitis.

Analysis of the Expression Profiles of Inflammation-regulating microRNAs in Serum and Tear Samples From Subjects With Allergic Conjunctivitis.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07385495
Acronym
OJO-miR
Enrollment
40
Registered
2026-02-04
Start date
2026-01-05
Completion date
2027-07-05
Last updated
2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conjunctivitis, Allergic

Keywords

microRNA, Tears, Serum, Ocular Surface, inflammation

Brief 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. 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.

Interventions

None listed

Sponsors

Instituto de Oftalmología Fundación Conde de Valenciana
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
5 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* 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. 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Expression of inflammation-regulatory microRNAs in tear samplesBaselineRelative 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 samplesBaselineRelative 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.

Secondary

MeasureTime frameDescription
Diagnostic performance of candidate microRNAsBaselineEvaluation 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).

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026