Quality of Life In Patients With Allergic Conjunctivitis In Treatment With Sublingual Allergen Immunotherapy In A Referral Ophthalmological Hospital

NCT07149298 | Active Not Recruiting DMC

• 3 other identifiers: CEI-2024/05/03CB-013-2024CI-014-2024
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate both clinical changes and quality-of-life outcomes in patients with allergic conjunctivitis treated with allergen-specific immunotherapy, integrating objective clinical parameters and validated quality-of-life measures to obtain a comprehensive view of the therapeutic impact.

Conditions

Allergic Conjunctivitis of Both Eyes

Keywords

Allergic Conjuntivitis; Allergy; Allergen; Life Quality; Allergen Immunotherapy

Outcome Measures

Primary Outcomes (3)

• Quality of life evaluated by the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Spanish version for Mexico in patients with Allergic Conjunctivitis treated with sublingual allergen immunotherapy.

  To evaluate the quality of life in patients with Allergic Conjunctivitis treated with sublingual allergen immunotherapy using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Spanish version for Mexico. This questionnaire features 28 items grouped in 7 domains: activities, sleep, other symptoms, practical problems, nasal symptoms, eye symptoms, emotional. For each item, the minimum score is 0 and the maximum score is 6. After the questionnaire is completed, a mean score is calculated. A higher overall score indicates a poorer quality of life.

  Before Sublingual Immunotherapy

• Quality of life in patients with Allergic Conjunctivitis treated with sublingual allergen immunotherapy evaluated using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Spanish version for Mexico.

  To evaluate the quality of life in patients with Allergic Conjunctivitis during 6 months of sublingual allergen immunotherapy using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Spanish version for Mexico. This questionnaire features 28 items grouped in 7 domains: activities, sleep, other symptoms, practical problems, nasal symptoms, eye symptoms, emotional. For each item, the minimum score is 0 and the maximum score is 6. After the questionnaire is completed, a mean score is calculated. A higher overall score indicates a poorer quality of life.

  From enrollment to the end of the 6th month of Allergen Immunotherapy treatment

• Quality of life in patients with Allergic Conjunctivitis treated with sublingual allergen immunotherapy using Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Spanish version for Mexico.

  To evaluate quality of life in patients with Allergic Conjunctivitis after completing allergen-specific sublingual immunotherapy using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Spanish version for Mexico. This questionnaire features 28 items grouped in 7 domains: activities, sleep, other symptoms, practical problems, nasal symptoms, eye symptoms, emotional. For each item, the minimum score is 0 and the maximum score is 6. After the questionnaire is completed, a mean score is calculated. A higher overall score indicates a poorer quality of life.

  From enrollment until 3 years of treatment with sublingual immunotherapy

Study Arms (1)

Patients diagnosed with conjunctivitis and treated with Sublingual Allergen Immunotherapy

100 patients who attended the Conde de Valenciana Institute's Immunology Department from 2014 to 2023, diagnosed with conjunctivitis, treated with allergen-specific sublingual immunotherapy, completed all 10 vials of treatment, and completed at least eight quality-of-life questionnaires.

Eligibility Criteria

• Age: 6 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 patients who attended the Conde de Valenciana Institute's Immunology Department from 2018 to 2023, diagnosed with conjunctivitis, treated with allergen-specific sublingual immunotherapy, completed 3 years of treatment, and completed at least eight quality-of-life questionnaires.

You may qualify if:

• Patient records containing complete information
• Both sexes
• Age range: 6 to 86 years
• Between 2018 and 2023
• Diagnosed with allergic conjunctivitis
• Who have received treatment with allergen-specific sublingual immunotherapy
• With 8 assessments from the immunology and cornea department
• With 7 quality of life questionnaires completed by the patient

You may not qualify if:

• Patient records for other inflammatory ocular conditions
• Those with chronic diseases
• Those who have received naturopathic or immunomodulatory treatment during the follow-up period for allergen-specific sublingual immunotherapy

Sponsors & Collaborators

• Instituto de Oftalmología Fundación Conde de Valenciana: lead

Study Sites (1)

Instituto de Oftalmología FAP Conde de Valenciana

Mexico City, 06800, Mexico

Location

Related Publications (4)

• Sanchez-Hernandez MC, Montero J, Rondon C, Benitez del Castillo JM, Velazquez E, Herreras JM, Fernandez-Parra B, Merayo-Lloves J, Del Cuvillo A, Vega F, Valero A, Panizo C, Montoro J, Matheu V, Lluch-Bernal M, Gonzalez ML, Gonzalez R, Dordal MT, Davila I, Colas C, Campo P, Anton E, Navarro A; SEAIC 2010 Rhinoconjunctivitis Committee; Spanish Group Ocular Surface-GESOC. Consensus document on allergic conjunctivitis (DECA). J Investig Allergol Clin Immunol. 2015;25(2):94-106.

  PMID: 25997302 BACKGROUND

• Devillier P, Dreyfus JF, Demoly P, Calderon MA. A meta-analysis of sublingual allergen immunotherapy and pharmacotherapy in pollen-induced seasonal allergic rhinoconjunctivitis. BMC Med. 2014 May 1;12:71. doi: 10.1186/1741-7015-12-71.

  PMID: 24885894 BACKGROUND

• Calderon-Ezquerro, M. C., Guerrero-Guerra, C., Galán, C., Serrano-Silva, N., Guidos-Fogelbach, G., Jiménez-Martínez, M. C., Larenas-Linnemann, D., López Espinosa, E. D., & Ayala-Balboa, J. (2018). Pollen in the atmosphere of Mexico City and its impact on the health of the pediatric population. Atmospheric Environment (Oxford, England: 1994), 186, 198-208. https://doi.org/10.1016/j.atmosenv.2018.05.006

  BACKGROUND

• Barrón-Campos, A., Velázquez-Samano, G., Velasco-Medina, A., Barrón-Soto, M. (2024). Evaluación de la calidad de vida de pacientes con rinitis alérgica por medio del cuestionario Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). Anales de Otorrinolaringología Mexicana 69:4. https://doi.org/10.24245/aorl.v69i4.10165

  BACKGROUND

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 29, 2025
• Study Start: March 24, 2014
• Primary Completion: October 9, 2023
• Study Completion: March 1, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After publication
• Access Criteria: The information will be completely public.

Locations

ME (1)