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

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.

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Key information

Conditions

Allergic Conjunctivitis of Both Eyes Hypersensitivity Immune System Diseases

Age range

6 year–86 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto de Oftalmología FAP Conde de Valenciana

Mexico City, 06800, Mexico

About this study

BACKGROUND: Allergic conjunctivitis (AC) is an inflammatory disease of the ocular surface that may be affecting people's quality of life. Studies have shown that allergic diseases are a risk factor for depression, sleep problems, and affect the patient's mood. Allergen-specific sublingual immunotherapy has been shown to be beneficial for the treatment of asthma and allergic rhinitis.

JUSTIFICATION: There are no studies demonstrating whether allergen-specific sublingual immunotherapy improves the different dimensions of quality of life affected by allergic conjunctivitis.

HYPOTHESIS: Quality of life in allergic conjunctivitis will improve with the administration of allergen-specific sublingual immunotherapy.

GENERAL OBJECTIVE: To define changes in quality of life in patients with allergic conjunctivitis before, during, and after allergen-specific sublingual immunotherapy using a standardized quality of life questionnaire at an ophthalmology referral hospital.

MATERIAL AND METHODS: A retrospective, observational, and longitudinal study will be conducted, reviewing 100 patient records of patients who attended the Immunology Department of the Conde de Valenciana Institute from 2018 to 2023, diagnosed with conjunctivitis, treated with allergen-specific sublingual immunotherapy, completed all 3 years of treatment, and completed at least 8 quality of life questionnaires.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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.

Time frame: Before Sublingual 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.
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.

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

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

Time frame: From enrollment until 3 years of treatment with sublingual immunotherapy

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.

Sponsors and collaborators

Lead sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Other

Registry information

Acronym: CVCA

Important dates

Study start: 2014
Primary completion: 2023
Study completion: 2026
First posted: Aug 29, 2025
Registry last updated: Sep 8, 2025

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.

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