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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	6 Years - 86 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07149298
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Instituto de Oftalmología Fundación Conde de Valenciana
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	Mexico
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Allergic Conjunctivitis of Both Eyes

Additional Details

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.

Arms & Interventions

Arms

: 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.

Interventions

Contact a Trial Team

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International Sites

Mexico City 3530597, Mexico

Status

Address

Instituto de Oftalmología FAP Conde de Valenciana

Mexico City 3530597, , 06800

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