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This Study Examines Whether Personality Traits Influence the Frequency or Severity of Ocular Adverse Effects Reported by Patients Using Glaucoma Medications. The Findings May Identify Patients at Greater Risk of Intolerance and Support More Personalized Treatment and Counselling. (Adverse Events)

Personality Traits and Their Relation to Ocular Adverse Effects From Glaucoma Medications

The goal of this observational study is to learn whether personality traits are related to eye side effects from glaucoma medications in adults who currently use or previously used these medications.

The main questions this study aims to answer are:

Are certain personality traits associated with the occurrence or severity of eye side effects from glaucoma medications? Do personality traits differ between people who experience these side effects and those who do not?

Participants will complete a questionnaire that measures five personality traits: openness, conscientiousness, extraversion, agreeableness, and neuroticism. They will also provide basic demographic information. The researchers will review participants' medical records to collect information about their glaucoma medications and any related eye side effects, including the type and frequency of side effects and whether treatment was changed because of them.

Participation involves one session lasting approximately 30 minutes. Questionnaires may be completed securely online or in person at the clinic. The study will include approximately 352 adults. No treatment will be assigned or changed as part of this study.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Glaucoma is a chronic eye disease that can cause irreversible vision loss. Lowering intraocular pressure is the principal strategy used to reduce the risk of disease progression. Topical medications are commonly used as first-line or adjunctive treatment, either alone or in combination with laser or surgical therapy. Although effective, glaucoma medications may cause ocular adverse effects such as dryness, irritation, redness, allergic reactions, inflammation, eyelash growth, changes in iris or periocular skin pigmentation, and changes in the tissues surrounding the eye. These adverse effects may affect comfort, adherence to treatment, and the need to modify or discontinue therapy.

The type and severity of adverse effects vary considerably among individuals. This variability may be related to the medication used, its preservatives, the duration of treatment, patient characteristics, or differences in how symptoms are perceived and reported. Personality traits may influence a person's awareness, interpretation, reporting, and tolerance of medication-related symptoms. However, the possible relationship between personality traits and ocular adverse effects from glaucoma medications has not been well studied.

The primary objective of this observational study is to evaluate the relationship between personality traits and ocular adverse effects in adults who are currently being treated, or were previously treated, with one or more glaucoma medications. The study will examine whether particular personality traits are associated with the occurrence and severity of ocular adverse effects. It will also compare the personality profiles of participants who have experienced specified medication-related ocular adverse effects with those of participants who have not.

Personality will be assessed using a questionnaire based on the Five-Factor Model. This widely used model describes personality across five domains: openness, conscientiousness, extraversion, agreeableness, and neuroticism. The study will investigate whether scores in these domains are associated with the type, frequency, or severity of ocular adverse effects and with treatment changes made because of these effects.

Approximately 352 adults aged 18 years or older will be recruited. Eligible participants must have a diagnosis of glaucoma and must currently be using, or have previously used, at least one glaucoma medication. Individuals with serious anxiety or depression that was present before the initiation of glaucoma treatment will not be eligible, as these conditions may affect the assessment of personality traits or the reporting of medication-related symptoms.

This is an observational case-control study. Participants will not be assigned to a treatment, and their glaucoma care will not be changed as part of the research. Participants who have experienced ocular adverse effects related to glaucoma medications will be compared with participants who have not experienced the adverse effects of interest.

Participation will involve one study session lasting approximately 30 minutes. The session may be completed remotely through Qualtrics, a secure web-based survey platform, or in person at the McGill Academic Eye Centre, according to the participant's preference. Questionnaires will be available in English and French.

During the study session, participants will complete the Five-Factor Model personality questionnaire by rating their agreement or disagreement with statements about their usual thoughts, feelings, and behaviours. Participants will also complete a brief demographic questionnaire that collects information such as age, gender, and ethnicity.

The research team will review relevant information from participants' medical records. Information collected will include the glaucoma medications used, medication type, dosage, duration of treatment, documented ocular adverse effects, the type and frequency of these effects, and any related changes to treatment. Questionnaire responses will be analyzed together with the clinical information to identify possible associations between personality traits and medication-related ocular adverse effects.

The study does not involve an experimental medication, additional clinical testing, or any change to the participant's usual treatment. There is no expected direct medical benefit to participants. The principal foreseeable risk is a potential breach of confidentiality. Participants will be identified in the research database by a study code, and identifying information will be stored separately from study data. Study information will be retained for seven years and may be presented at scientific meetings or published in scientific journals in a form that does not identify individual participants.

The findings may improve understanding of why patients differ in their experience and reporting of glaucoma medication side effects. If meaningful associations are identified, the results could support future research into more individualized approaches to medication counselling, monitoring, treatment selection, and management of adverse effects.

Tipo di studio

Osservativo

Iscrizione (Stimato)

352

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Approximately 352 adults with glaucoma who are currently receiving or have previously received treatment with one or more glaucoma medications will be recruited from the McGill Academic Eye Centre and the Lachine Hospital Ophthalmology Clinic.

Participants will be classified into two groups:

Cases: Participants with at least one documented ocular adverse effect from a glaucoma medication that resulted in discontinuation of the medication.

Controls: Participants without a documented significant ocular adverse effect resulting in medication discontinuation.

Approximately 176 participants will be included in each group

Descrizione

Inclusion Criteria:

  • Age 18 years or older.
  • Diagnosis of glaucoma.
  • Current or previous treatment with one or more glaucoma medications.
  • Able to provide informed consent.
  • Able to complete the study questionnaires in English or French.

Exclusion Criteria:

  • Uncontrolled anxiety or depression that was present before glaucoma medication treatment began.
  • Unable to provide informed consent.
  • Unable to complete the study questionnaires in English or French.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Case
Participants with at least one documented ocular adverse effect from a glaucoma medication that resulted in discontinuation of the medication.
There is no intervention
Control
Participants without a documented significant ocular adverse effect resulting in medication discontinuation.
There is no intervention

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Difference in Five-Factor Model neuroticism scores between participants with and without significant ocular adverse reactions
Lasso di tempo: Assessed once during the single study session, lasting approximately 30 minutes.

Neuroticism will be measured using the neuroticism domain of the Five-Factor Model personality questionnaire. Mean neuroticism scores will be compared between:

Cases: participants who experienced at least one ocular adverse effect from a glaucoma medication that resulted in discontinuation of the medication.

Controls: participants who did not experience a significant ocular adverse effect resulting in medication discontinuation.

Higher neuroticism scores indicate a higher level of the neuroticism personality trait.

Assessed once during the single study session, lasting approximately 30 minutes.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Hady Saheb, MD MPH, MUHC RI

Pubblicazioni e link utili

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Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

25 febbraio 2026

Completamento primario (Stimato)

1 luglio 2027

Completamento dello studio (Stimato)

1 agosto 2027

Date di iscrizione allo studio

Primo inviato

28 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 luglio 2026

Primo Inserito (Effettivo)

31 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

31 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2026-10903

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

A final decision regarding sharing de-identified individual participant data has not yet been made. Any future sharing will be subject to participant consent, institutional and research ethics requirements, applicable privacy protections, and journal or funder policies.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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