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.
Study Overview
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ana Hernandez, MD
- Phone Number: 15149341934
- Email: ana.ramirezhernandez@mail.mcgill.ca
Study Contact Backup
- Name: Hady Saheb, MD MPH
- Phone Number: 514-934-1934
- Email: hady.saheb@mcgill.ca
Study Locations
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Quebec
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Montreal, Quebec, Canada
- Recruiting
- McGill University Health Center
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Contact:
- Ana Hernandez, MD
- Phone Number: 514-934-1934
- Email: ana.ramirezhernandez@mail.mcgill.ca
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Case
Participants with at least one documented ocular adverse effect from a glaucoma medication that resulted in discontinuation of the medication.
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There is no intervention
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Control
Participants without a documented significant ocular adverse effect resulting in medication discontinuation.
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There is no intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Difference in Five-Factor Model neuroticism scores between participants with and without significant ocular adverse reactions
Time Frame: Assessed once during the single study session, lasting approximately 30 minutes.
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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.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Hady Saheb, MD MPH, MUHC RI
Publications and helpful links
General Publications
- Baudouin C. Detrimental effect of preservatives in eyedrops: implications for the treatment of glaucoma. Acta Ophthalmol. 2008 Nov;86(7):716-26. doi: 10.1111/j.1755-3768.2008.01250.x. Epub 2008 Jun 3.
- Inoue K. Managing adverse effects of glaucoma medications. Clin Ophthalmol. 2014 May 12;8:903-13. doi: 10.2147/OPTH.S44708. eCollection 2014.
- Gazzard G, Konstantakopoulou E, Garway-Heath D, Adeleke M, Vickerstaff V, Ambler G, Hunter R, Bunce C, Nathwani N, Barton K; LiGHT Trial Study Group. Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial: Six-Year Results of Primary Selective Laser Trabeculoplasty versus Eye Drops for the Treatment of Glaucoma and Ocular Hypertension. Ophthalmology. 2023 Feb;130(2):139-151. doi: 10.1016/j.ophtha.2022.09.009. Epub 2022 Sep 17.
- Davis C, Ralevski E, Kennedy SH, Neitzert C. The role of personality factors in the reporting of side effect complaints to moclobemide and placebo: a study of healthy male and female volunteers. J Clin Psychopharmacol. 1995 Oct;15(5):347-52. doi: 10.1097/00004714-199510000-00007.
- Dahl AA, Smedsland SK, Vandraas KF, Bohn SK, Falk RS, Kiserud CE, Reinertsen KV. High neuroticism is associated with common late adverse effects in a nationwide sample of long-term breast cancer survivors. Breast Cancer Res Treat. 2023 Nov;202(1):97-104. doi: 10.1007/s10549-023-07055-2. Epub 2023 Aug 1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-10903
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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