Allergic Conjunctivitis of Both EyesCVCANCT07149298
Quality of Life In Patients With Allergic Conjunctivitis In Treatment With Sublingual Allergen Immunotherapy In A Referral Ophthalmological Hospital
An observational study of Allergic Conjunctivitis of Both Eyes, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 86 years
- Conditions the study is for
- Allergic Conjunctivitis of Both Eyes
- How many people
- 100 participants
- Where
- 1 siteMexico
- Study dates
- 24 Mar 2014to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 86 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Mexico1 site
Instituto de Oftalmología FAP Conde de Valenciana
Mexico City, 06800
About this study
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.
Read the detailed description
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.
- Conditions
- Allergic Conjunctivitis of Both Eyes
- Keywords
- Allergic Conjuntivitis, Allergy, Allergen, Life Quality, Allergen Immunotherapy
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From enrollment until 3 years of treatment with sublingual immunotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start24 Mar 2014
- Primary completion9 Oct 2023
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Allergic Conjunctivitis of Both EyesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149298
- Sponsor's protocol ID
- CEI-2024/05/03
- Other IDs
- CB-013-2024, CI-014-2024
- Acronym
- CVCA
- Status last verified
- Sep 2025
- First submitted
- 21 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As Supplementary Material in the publication
Publications
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.
PubMed 25997302Devillier 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.
PubMed 24885894Calderon-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
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life In Patients With Allergic Conjunctivitis In Treatment With Sublingual Allergen Immunotherapy In A Referral Ophthalmological Hospital
- ClinicalTrials.gov ID
- NCT07149298
- Acronym / sponsor ID
- CVCA / CEI-2024/05/03
- Conditions
- Allergic Conjunctivitis of Both Eyes
- Keywords
- Allergic Conjuntivitis, Allergy, Allergen, Life Quality, Allergen Immunotherapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de ValencianaUniversity, hospital or other
- Study start
- 24 Mar 2014 (actual)
- Primary completion
- 9 Oct 2023 (actual)
- Study completion
- Mar 2026 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- Patient records containing complete information
- Both sexes
- Age range: 6 to 86 years
- Between 2018 and 2023
- Diagnosed with allergic conjunctivitis
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Background: PubMed 25997302Sanchez-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.
- Background: PubMed 24885894Devillier 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.
- BackgroundCalderon-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
- BackgroundBarrón-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
- Individual participant dataSharing planned: Yes. As Supplementary Material in the publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Conjunctivitis of Both Eyes, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07149298, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.