OJO-miR: microRNA Expression in Allergic Conjunctivitis.

NCT07385495 | Active Not Recruiting DMC

• 3 other identifiers: CEI-2025/09/05Research CommitteeBiosecurity Committee
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Conjunctivitis, Allergic

Keywords

microRNA; Tears; Serum; Ocular Surface; inflammation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline

Secondary Outcomes (1)

• Diagnostic performance of candidate microRNAs

  Baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 5 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Oftalmología Fundación Conde de Valenciana: lead

Study Sites (1)

Instituto de Oftalmología FAP Conde de Valenciana, IAP Sede Centro

Mexico City, Mexico City, 06800, Mexico

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood: Samples are collected following the Institute's Immunology Department manual after verifying informed consent. Personnel must use hand hygiene, masks, and gloves. Venous blood is obtained by venipuncture in Vacutainer tubes with separator gel. Serum is separated by centrifugation and stored at -20°C. Tears: Collected according to Santacruz et al. (2015). Personnel must use hand hygiene, gloves, and masks. 20 µL of sterile saline is instilled into each eye. Tear film is collected from the lower lateral meniscus using borosilicate capillaries. Samples are stored in microtubes at -20°C.

MeSH Terms

Conditions

Conjunctivitis, Allergic; Lacerations; Inflammation

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Immunology Department, Research Unit

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 4, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): January 5, 2027
• Study Completion (Estimated): July 5, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)