GlaucomaAdverse EventsNCT07739784
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.
An observational study of Glaucoma, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- How many people
- 352 participants
- Where
- 1 siteCanada
- Study dates
- 25 Feb 2026to 1 Aug 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McGill University Health Center
Montreal, Quebec
Ana Hernandez, MD, 514-934-1934, ana.ramirezhernandez@mail.mcgill.ca
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Glaucoma
- Being tested
- No Interventions
- Keywords
- adverse events, Personality traits, glaucoma
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
There is no intervention
| Study group | Role | What they receive |
|---|---|---|
| Case | Participants with at least one documented ocular adverse effect from a glaucoma medication that resulted in discontinuation of the medication. Receives: Other: No Interventions | |
| Control | Participants without a documented significant ocular adverse effect resulting in medication discontinuation. Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Five-Factor Model neuroticism scores between participants with and without significant ocular adverse reactions
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.
Measured: Assessed once during the single study session, lasting approximately 30 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start25 Feb 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hady.saheb, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Hady Saheb, MD MPH, Principal investigator, MUHC RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739784
- Sponsor's protocol ID
- 2026-10903
- Acronym
- Adverse Events
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
Inoue K. Managing adverse effects of glaucoma medications. Clin Ophthalmol. 2014 May 12;8:903-13. doi: 10.2147/OPTH.S44708. eCollection 2014.
PubMed 24872675Gazzard 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.
PubMed 36122660Davis 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.
PubMed 8830066Dahl 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.
PubMed 37528264Baudouin 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.
PubMed 18537937
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personality Traits and Their Relation to Ocular Adverse Effects From Glaucoma Medications
- ClinicalTrials.gov ID
- NCT07739784
- Acronym / sponsor ID
- Adverse Events / 2026-10903
- Conditions
- Glaucoma
- Keywords
- adverse events, Personality traits, glaucoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 31 Jul 2026 (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 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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: No InterventionsParticipants with at least one documented ocular adverse effect from a glaucoma medication that resulted in discontinuation of the medication. |
| Control | – | Other: No InterventionsParticipants without a documented significant ocular adverse effect resulting in medication discontinuation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionsThere is no intervention | Other | Case, Control |
Primary outcome
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.
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.
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 31 Jul 2026.
- Results publication: PubMed 24872675Inoue K. Managing adverse effects of glaucoma medications. Clin Ophthalmol. 2014 May 12;8:903-13. doi: 10.2147/OPTH.S44708. eCollection 2014.
- Results publication: PubMed 36122660Gazzard 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.
- Results publication: PubMed 8830066Davis 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.
- Results publication: PubMed 37528264Dahl 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.
- Results publication: PubMed 18537937Baudouin 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.
- Individual participant dataSharing planned: Undecided. 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.
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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.
Hady Saheb, MD MPH principal investigator
MUHC RI
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 Glaucoma, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 5 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: looking for participants now, as of the sponsor's last update on 31 Jul 2026. 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 Canada. 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?
Contact Ana Hernandez, MD (15149341934, ana.ramirezhernandez@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). 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 NCT07739784, which also lists 5 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 31 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.