Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07385495

OJO-miR: microRNA Expression in 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

5 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto de Oftalmología FAP Conde de Valenciana, IAP Sede Centro

Mexico City, 06800, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Diagnostic performance of candidate microRNAs

    Time frame: Baseline

    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).

Sponsors and collaborators

Lead sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Other

Registry information

Official study title

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

Acronym: OJO-miR

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 4, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.