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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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

352

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Difference in Five-Factor Model neuroticism scores between participants with and without significant ocular adverse reactions
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Hady Saheb, MD MPH, MUHC RI

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

25. februar 2026

Primær fullføring (Antatt)

1. juli 2027

Studiet fullført (Antatt)

1. august 2027

Datoer for studieregistrering

Først innsendt

28. juli 2026

Først innsendt som oppfylte QC-kriteriene

30. juli 2026

Først lagt ut (Faktiske)

31. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026-10903

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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