Medication AdherenceNCT03506568
A Universal Eye Drop Adherence Monitor to Measure and Improve Adherence to Ocular Medications
A study testing Devers Drop Device (D3) app in people with Medication Adherence and Glaucoma, run by Universal Adherence LLC at 1 site in United States.
Trial summary
Glaucoma is the second leading cause of visual impairment worldwide. Eye drop medications reduce vision loss from glaucoma by at least 60%, but eye drops must be taken every day to be effective. However, adherence to eye drop treatment is poor with only 50% of patients regularly taking their prescribed eye drops. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Adherence, Glaucoma
- What is being tested?
- Devers Drop Device (D3) app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2020to 4 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are prescribed latanoprost eye drop to be used once per day at bedtime, and own a functioning smartphone and have a password-protected home wireless connection.
Who cannot join
- Patients who currently use smartphone medication reminders and those with severe cognitive impairment limiting their ability to understand a questionnaire.
Trial locations and contacts
1 site in 1 country.
About this study
Glaucoma is the second leading cause of visual impairment worldwide. Eye drop medications reduce vision loss from glaucoma by at least 60%, but eye drops must be taken every day to be effective. However, adherence to eye drop treatment is poor with only 50% of patients regularly taking their prescribed eye drops. The investigators are developing the Devers Drop Device (D3) eye drop monitor to accurately measure eye drop cap removal and to improve eye drop-taking behavior. The investigators will test eye drop adherence with the D3 device in a randomized, prospective clinical trial.
Read the detailed description
Universal Adherence is an emerging medical device company dedicated to improving adherence to ocular medications through innovative technical solutions. The Devers Drop Device (D3) will accurately track when a patient removes an eye drop bottle cap, communicate usage data wirelessly to a database that researchers can access, and send alerts to patients when a medication is due. In addition to helping patients maintain their dosing schedule, the D3 will also provide adherence information to researchers and eye care providers, which will help to understand poor treatment outcomes and to develop improved treatment strategies.The clinical benefits of the device in improving adherence will initially be assessed and targeted towards glaucoma, but the ability of the device to be attached to all FDA-approved eye drop bottle caps will make this device attractive to all patients that need consistent daily use of eye drops.
Randomized, prospective clinical trial: The investigators will enroll 50 participants (25 male, 25 female) into a prospective trial with duration of up to 50 days. The inclusion criteria are those who are prescribed latanoprost eye drop to be used once per day at bedtime, and own a functioning Android or Apple iphone smartphone (iOs) with Bluetooth and cellular connectivity. The investigators will exclude patients who currently use smartphone medication reminders and those with severe cognitive impairment limiting their ability to understand a questionnaire. The 50-day period is useful for glaucoma studies because patients revert to their normal dosing pattern within two weeks after their last visit. This study will include two stages: Stage 1) a 25-day period evaluating baseline patient adherence with the D3 device; and Stage 2) a subsequent 25-day period to determine the effect of no reminder versus daily reminder using the D3 app, which includes integrated audio and visual reminders.
- Conditions
- Medication Adherence, Glaucoma
- Being tested
- Devers Drop Device (D3) app
- Keywords
- Adherence, Medication, Glaucoma, Device
- Medical subject headings
- Medication Adherence, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Devers Drop Device (D3) appDevice
A universal eye drop cap monitor that accurately measures and improves eye drop-taking behavior.
| Study group | Role | What they receive |
|---|---|---|
| Control - no reminder | No intervention | For Group 1, there will be no changes to their instructions or smart phone, which is the most common clinical situation. |
| Integrated daily reminder using the D3 app | Experimental | For Group 2, they will have their D3 app turned on to deliver both a push notification reminder to their smart phone and audio and visual reminders to their D3 device. Receives: Device: Devers Drop Device (D3) app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance Percentage
Compliance percentage by dividing the number of days the dose monitor recorded dosing within 3 hours of the prescribed time by the number of days in the study cycle
Measured: 50 days
Secondary outcomes (1)
Patient Satisfaction
The investigators will also measure the participants' satisfaction with the dose monitor using a short Likert questionnaire. The questionnaire will include 5 questions. Each question will offer choices 1-5 with an overall minimum summed score of 5 and a maximum summed score of 25. Higher score will indicate higher satisfaction.
Measured: 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start2 Oct 2020
- Primary completion4 Jun 2021
- Study completion4 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Medication AdherenceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universal Adherence LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), Oregon State University, National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Steve L Mansberger, MD, Principal investigator, Universal Adherence LLCDavid Porter, PhD, Principal investigator, Oregon State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506568
- Sponsor's protocol ID
- UniversalAdherence
- Other IDs
- 1R41EY028807-01
- Status last verified
- Feb 2023
- First submitted
- 14 Apr 2018
- Last updated
- 21 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will only be shared internally with co-investigators and those performing analysis of data.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Universal Eye Drop Adherence Monitor to Measure and Improve Adherence to Ocular Medications
- ClinicalTrials.gov ID
- NCT03506568
- Acronym / sponsor ID
- UniversalAdherence
- Conditions
- Medication Adherence, Glaucoma
- Keywords
- Adherence, Medication, Glaucoma, Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universal Adherence LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), Oregon State University, National Eye Institute (NEI)
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 4 Jun 2021 (actual)
- First posted
- 24 Apr 2018 (actual)
- Results
- Posted 21 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Glaucoma is the second leading cause of visual impairment worldwide. Eye drop medications reduce vision loss from glaucoma by at least 60%, but eye drops must be taken every day to be effective. However, adherence to eye drop treatment is poor with only 50% of patients regularly taking their prescribed eye drops. The investigators are developing the Devers Drop Device (D3) eye drop monitor to accurately measure eye drop cap removal and to improve eye drop-taking behavior. The investigators will test eye drop adherence with the D3 device in a randomized, prospective clinical trial.
Detailed description
Universal Adherence is an emerging medical device company dedicated to improving adherence to ocular medications through innovative technical solutions. The Devers Drop Device (D3) will accurately track when a patient removes an eye drop bottle cap, communicate usage data wirelessly to a database that researchers can access, and send alerts to patients when a medication is due. In addition to helping patients maintain their dosing schedule, the D3 will also provide adherence information to researchers and eye care providers, which will help to understand poor treatment outcomes and to develop improved treatment strategies.The clinical benefits of the device in improving adherence will initially be assessed and targeted towards glaucoma, but the ability of the device to be attached to all FDA-approved eye drop bottle caps will make this device attractive to all patients that need consistent daily use of eye drops.
Randomized, prospective clinical trial: The investigators will enroll 50 participants (25 male, 25 female) into a prospective trial with duration of up to 50 days. The inclusion criteria are those who are prescribed latanoprost eye drop to be used once per day at bedtime, and own a functioning Android or Apple iphone smartphone (iOs) with Bluetooth and cellular connectivity. The investigators will exclude patients who currently use smartphone medication reminders and those with severe cognitive impairment limiting their ability to understand a questionnaire. The 50-day period is useful for glaucoma studies because patients revert to their normal dosing pattern within two weeks after their last visit. This study will include two stages: Stage 1) a 25-day period evaluating baseline patient adherence with the D3 device; and Stage 2) a subsequent 25-day period to determine the effect of no reminder versus daily reminder using the D3 app, which includes integrated audio and visual reminders.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control - no reminder | No intervention | –For Group 1, there will be no changes to their instructions or smart phone, which is the most common clinical situation. |
| Integrated daily reminder using the D3 app | Experimental | Device: Devers Drop Device (D3) appFor Group 2, they will have their D3 app turned on to deliver both a push notification reminder to their smart phone and audio and visual reminders to their D3 device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are prescribed latanoprost eye drop to be used once per day at bedtime, and own a functioning smartphone and have a password-protected home wireless connection.
Key exclusion criteria (1 listed)
- Patients who currently use smartphone medication reminders and those with severe cognitive impairment limiting their ability to understand a questionnaire.
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 |
|---|---|---|
| Devers Drop Device (D3) appA universal eye drop cap monitor that accurately measures and improves eye drop-taking behavior. | Device | Integrated daily reminder using the D3 app |
Primary outcome
Compliance Percentage
Time frame: 50 days
Compliance percentage by dividing the number of days the dose monitor recorded dosing within 3 hours of the prescribed time by the number of days in the study cycle
1 secondary outcome
Patient Satisfaction
Time frame: 50 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. IPD will only be shared internally with co-investigators and those performing analysis of data.
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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. This study is not recruiting at the moment.
Steve L Mansberger, MD principal investigator
Universal Adherence LLC
David Porter, PhD principal investigator
Oregon State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Devers Drop Device (D3) app in people with Medication Adherence and Glaucoma, run by Universal Adherence LLC at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Feb 2023. 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 United States. 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?
Yes. Results are posted in the registry (first posted 21 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance Percentage (time frame: 50 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2023.