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Glaucoma Medication AdherenceEYE-PACIPNCT07793474

Eye Patient Adherence and Compliance Study

A study testing Eye Droppers, Eye Educate and Eye Coordinate in people with Glaucoma Medication Adherence and Glaucoma Patients, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study looks at ways to help people with glaucoma take their eye drops regularly and attend their clinic appointments. Each participant will be asked about the main challenges they face, such as forgetfulness, difficulty using drops, lack of transportation, or limited understanding of their condition. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Eye Droppers, Eye Educate and Eye Coordinate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
189 participants
Where
1 siteCanada
Study dates
1 Sep 2026to 31 Mar 2028
Phase
Interventional
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

Who may be able to join

None listed.

Who cannot join

  • Participants will be excluded if they meet any of the following criteria:
  • Significant cognitive impairment, neurodegenerative disease, or severe psychiatric illness limiting participation or understanding of the intervention
  • Participation in another interventional study targeting glaucoma adherence or follow-up
  • Anticipated inability to complete 12-month follow-up (e.g., planned relocation or transfer of care outside the study catchment area)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ladun O Odediran, MSc. contact

(905)573-7777 ext. 38504

odedirao@mcmaster.ca

Canada1 site
  • St Joseph's Regional Eye Clinic

    Hamilton, Ontario, L8G 5E4

    Enitan A. Sogbesan, M.D., (905)573-7777 ext. 38311, sogbese@mcmaster.ca

Other trials in Canada

About this study

Official title: Eye Patient Adherence and Compliance Study-Intervention Program (EYE-PACIP): Improving Glaucoma Adherence and Compliance in High-risk Patients With a Multi-interventional Program

This study looks at ways to help people with glaucoma take their eye drops regularly and attend their clinic appointments. Each participant will be asked about the main challenges they face, such as forgetfulness, difficulty using drops, lack of transportation, or limited understanding of their condition. Based on their biggest challenge, participants will receive one type of support that is already part of usual care, such as education, reminders, help with applying drops, or assistance getting to appointments. The investigators will follow participants over time to see if this support improves how well they follow their treatment and their quality of life.

Read the detailed description

This study will enroll adult patients with glaucoma who are identified as being at high risk for poor medication adherence or inconsistent follow-up with clinic visits. Following informed consent, participants will undergo baseline assessments that include a structured questionnaire to identify barriers to adherence and compliance, as well as standardized tools to measure medication adherence and vision-related quality of life. Clinical information relevant to glaucoma management will be obtained as part of routine care.

Each participant will then be assigned to a single, tailored intervention based on their most significant self-identified barrier to care. These interventions reflect established components of standard glaucoma care and may include targeted education about the disease and its treatment, reminder systems to support medication use, training or assistance with proper eye drop administration, coordination of transportation for clinic visits, or enhanced care navigation and referral support. The goal is to provide individualized, practical support that directly addresses the participant's primary challenge.

All participants will continue to receive their usual ophthalmic care throughout the study period, and no experimental therapies will be introduced. Follow-up assessments will be conducted at multiple time points over approximately 12 months to evaluate changes in medication adherence, clinic attendance, and quality of life. These assessments will use the same validated tools administered at baseline to allow for comparison over time.

Data collected during the study will be analyzed to assess within-participant changes in outcomes following the intervention. The study will also explore patterns between types of barriers and improvements in adherence and related outcomes. The findings are intended to inform future approaches to improving glaucoma care by identifying practical, patient-centred strategies that can be integrated into routine clinical practice.

Being tested
Eye Droppers, Eye Educate, Eye Coordinate, Eye Help, Eye Refer
Keywords
Glaucoma, medication adherence, Treatment compliance, follow-up attendance, patient education, reminder systems, quality of life
Medical subject headings
Glaucoma, Medication Adherence, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eye DroppersBehavioural

    Participants in this arm receive individualized training and support to improve correct and consistent instillation of glaucoma eye drops. The intervention includes in-person or virtual instruction by the Eye Patient Adherence and Compliance Study-Intervention Program (EYE-PACIP) team on proper drop technique, use of assistive devices where needed, and caregiver training when applicable. Patients with significant physical or cognitive limitations may receive additional volunteer or home-care support. In long-term care settings, coordination with facility staff ensures adherence support. Reinforcement is provided through demonstration, return-demonstration, and follow-up monitoring of technique and adherence.

  • Eye EducateBehavioural

    Participants receive structured glaucoma education aimed at improving disease understanding, treatment awareness, and motivation for adherence. Education is delivered through one-on-one or group sessions at the clinic and includes standardized materials (pamphlets, videos, and resources from recognized ophthalmology organizations). Content covers disease chronicity, importance of lifelong treatment, risks of non-adherence, and medication side effects. Pre- and post-intervention assessments are used to evaluate knowledge improvement.

  • Eye CoordinateBehavioural

    This arm provides adherence support through structured reminder systems designed to reduce forgetfulness. Interventions include mobile phone alarms, calendar reminders, and physical reminder cards to track medication use. Weekly follow-up calls are conducted during the first month, followed by scheduled check-ins at 3, 6, and 12 months. Patients also report missed doses through logs or reminder tools, which are reviewed during follow-up to reinforce adherence behaviours.

  • Eye HelpBehavioural

    Participants receive assistance to overcome transportation-related barriers to clinic attendance. The intervention includes coordination with community transportation services (e.g., volunteer drivers, community transport programs) and linkage to available support services. For patients in long-term care or retirement homes, mobile or outreach-based support may be arranged to facilitate continuity of follow-up care. The goal is to improve clinic attendance and reduce missed appointments.

  • Eye ReferBehavioural

    Participants receive enhanced access to ophthalmic assessment through mobile or outreach-based clinical support. A trained ophthalmic technician conducts home or facility-based assessments, including intraocular pressure measurement, optic nerve imaging, and portable visual field testing. Findings are reviewed by an ophthalmologist to guide timely management decisions. The intervention also includes strengthened referral coordination to reduce delays in specialist care and improve continuity between primary and specialist services.

Study groups in NCT07793474
Study groupRoleWhat they receive
Eye DroppersExperimentalTraining in proper eyedrop administration
Receives: Behavioral: Eye Droppers
Eye EducateExperimentalGlaucoma education sessions
Receives: Behavioral: Eye Educate
Eye CoordinateExperimentalReminder systems for medication use
Receives: Behavioral: Eye Coordinate
Eye HelpExperimentalTransportation support
Receives: Behavioral: Eye Help
Eye ReferExperimentalCare coordination and referral support
Receives: Behavioral: Eye Refer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Glaucoma Treatment Compliance Assessment Tool (GTCAT) Score from Baseline to 12 Months

    Medication adherence will be assessed using the 27-statement Glaucoma Treatment Compliance Assessment Tool-Short Form (GTCAT-S). The GTCAT-S assesses behavioural factors associated with glaucoma medication adherence, including knowledge, susceptibility, cues to action, self-efficacy, and treatment barriers. A derived adherence score ranges from 0 to 27, with higher scores indicating greater adherence to glaucoma treatment. The primary outcome will be the within-participant change in GTCAT-S score from baseline to 12 months, calculated as the 12-month score minus the baseline score. A positive change indicates improvement in medication adherence.

    Measured: Baseline and 12 months

Secondary outcomes (3)
  1. Follow-up compliance - Change in Follow-up Appointment Completion Rate

    Follow-up compliance will be assessed using clinic attendance records. For each participant, scheduled glaucoma follow-up appointments during the study period will be classified as completed, missed/no-show, or cancelled. The appointment completion rate will be calculated as the number of completed scheduled follow-up appointments divided by the total number of scheduled follow-up appointments, expressed as a percentage. Higher percentages indicate better follow-up compliance.

    Measured: baseline, 1, 3, 6, 9, and 12 months

  2. Vision-related quality of life - Change in Glaucoma Quality of Life-15 (GQL-15) Score

    Vision-related quality of life will be assessed using the 15-item Glaucoma Quality of Life-15 (GQL-15) questionnaire. Each activity is rated according to the degree of difficulty experienced because of vision, from 1 (no difficulty) to 5 (severe difficulty); a response of 0 indicates that the activity is not performed for reasons unrelated to vision. When all 15 items are scorable, the total GQL-15 score ranges from 15 to 75. Higher scores indicate greater vision-related difficulty and poorer quality of life. Change from baseline will be assessed at 6 and 12 months; a decrease in score indicates improvement in vision-related quality of life.

    Higher scores indicate greater participant satisfaction with the intervention, including perceived usefulness, clarity of education, ease of participation, communication with the EYE-PAC team, and overall experience.

    Measured: 6 months and 12 months.

  3. Activity limitation - Change in Glaucoma Activity Limitation-9 (GAL-9) Score

    Vision-related activity limitation will be assessed using the 9-item Glaucoma Activity Limitation-9 (GAL-9) questionnaire. Each item assesses difficulty performing a vision-dependent activity using a 5-category response scale ranging from 1 (no difficulty) to 5 (severe difficulty). If the raw item scores are summed, the total score ranges from 9 to 45, with higher scores indicating greater vision-related activity limitation. Change from baseline will be assessed at 6 and 12 months; a decrease in score indicates improvement in vision-related functioning.

    Measured: Time Frame: Baseline, 6 months and 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Participants are recruited into one out of five tailored, barrier-specific interventions based on their primary adherence challenge, with outcomes evaluated using a pre-post (within-subject) comparison over time.
Masking
None (open label)
Enrolment
189 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07793474
Sponsor's protocol ID
14021
Acronym
EYE-PACIP
Status last verified
Aug 2026
First submitted
4 May 2026
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be publicly shared due to the sensitive and potentially identifiable nature of ophthalmic clinical data, including detailed visual field results, imaging data, and longitudinal clinical histories. Given the relatively small, single-centre study population and the inclusion of detailed demographic and clinical variables, there is a potential risk of participant re-identification even after de-identification. However, aggregated and de-identified data may be made available upon reasonable request to the principal investigator, subject to institutional ethics approval and data-sharing agreements consistent with McMaster University and St. Joseph's Healthcare Hamilton policies.

Publications

  • Newman-Casey PA, Robin AL, Blachley T, Farris K, Heisler M, Resnicow K, Lee PP. The Most Common Barriers to Glaucoma Medication Adherence: A Cross-Sectional Survey. Ophthalmology. 2015 Jul;122(7):1308-16. doi: 10.1016/j.ophtha.2015.03.026. Epub 2015 Apr 24.

    PubMed 25912144
  • Okeke CO, Quigley HA, Jampel HD, Ying GS, Plyler RJ, Jiang Y, Friedman DS. Interventions improve poor adherence with once daily glaucoma medications in electronically monitored patients. Ophthalmology. 2009 Dec;116(12):2286-93. doi: 10.1016/j.ophtha.2009.05.026. Epub 2009 Oct 7.

    PubMed 19815286
  • Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.

    PubMed 16488940

Questions about this trial

What is this clinical trial studying?

A study testing Eye Droppers, Eye Educate and Eye Coordinate in people with Glaucoma Medication Adherence and Glaucoma Patients, run by St. Joseph's Healthcare Hamilton 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 0 inclusion and 4 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: opening soon, as of the sponsor's last update on 28 Aug 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 Ladun O Odediran, MSc. ((905)573-7777 ext. 38504, odedirao@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glaucoma Treatment Compliance Assessment Tool (GTCAT) Score from Baseline to 12 Months (time frame: Baseline and 12 months). 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 NCT07793474, which also lists 3 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 28 Aug 2026.

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