GlaucomaNCT07664943
The iD2: A Smart Eye Drop Cap Monitor for Eye Drop Adherence
A study testing Eye drop cap monitor in people with Glaucoma and Medication Adherence, run by Universal Adherence LLC.
Trial summary
Most patients with glaucoma use eye drops to lower their intraocular pressure. However, poor adherence to prescribed eye drop regimens can lead to significant loss of vision-related quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Medication Adherence
- What is being tested?
- Eye drop cap monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Aug 2027
- 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
- Age ≥ 18
- Taking at least one glaucoma drop daily
- A history of poor adherence when taking glaucoma eye drops. This is determined as an answer of 80% or less for the following question: "Over the past month, what percentage of your drops do you think you took correctly?"
- Owns a functioning smart phone with Bluetooth and cellular connectivity
Who cannot join
- Advanced cognitive impairment
- Current or expected pregnancy during the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Most patients with glaucoma use eye drops to lower their intraocular pressure. However, poor adherence to prescribed eye drop regimens can lead to significant loss of vision-related quality of life. This study will test the iDrop Device (iD2), a device-on-cap electronic platform monitor designed to accurately track when a research participant removes an eye drop bottle cap, wirelessly communicate usage data to a database accessible to researchers, and send on-demand alerts when a medication is due. A device capable of tracking eye drop usage and sending dosage alerts will test the hypothesis that electronic reminders improve medication adherence and help research subjects improve their eye drop taking behavior. While our primary focus is on glaucoma adherence, this device could also benefit those with other chronic eye conditions requiring regular eye drop treatment, such as dry eye, corneal endothelial disease, eye infections, and uveitis.
- Conditions
- Glaucoma, Medication Adherence
- Being tested
- Eye drop cap monitor
- Keywords
- iD2, Adherence, Medication, Glaucoma, Device
- Medical subject headings
- Glaucoma, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye drop cap monitorDevice
Also called iD2, iDrop Device
Eye drop cap monitor for improving adherence
| Study group | Role | What they receive |
|---|---|---|
| Reminders during Stage 2 of study | Experimental | Stage 2 of the study is a 45-day period with 1:1 random assignment to determine the effect of no reminders vs. smart cap reminders if the drop is not used within the designated time window. This arm will receive smart cap reminders. Receives: Device: Eye drop cap monitor |
| No reminders during Stage 2 of study | No intervention | Stage 2 of the study is a 45-day period with 1:1 random assignment to determine the effect of no reminders vs. smart cap reminders if the drop is not used within the designated time window. This arm will not receive smart cap reminders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adherence when Using the Dose Monitor
The iD2 device will track when the bottle cap is removed as a measure of medication adherence. Adherence will be measured throughout the study, comparing adherence when dose reminders are given against when no dose reminders are given.
Measured: 150 days
Secondary outcomes (1)
Participant Satisfaction with the Dose Monitor
A participant's satisfaction with the dose monitor is measured using a questionnaire administered during the last study visit. 8 questions will use a 1-5 Likert scale, with 1 corresponding to "Strongly Disagree" and 5 corresponding to "Strongly Agree" in response to statements regarding device satisfaction, such as "I would use this device again." 7 questions are open-ended.
Measured: 150 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The trial includes 4 stages: Stage 1) a 30-day run-in period using the iD2 smart cap monitor without any reminders; Stage 2) a 45-day period with 1:1 random assignment to determine the effect of no reminders vs. smart cap reminders if the drop is not used within the designated time window; Stage 3) A 45-day period in which all participants receive the reminders; and Stage 4) A 30-day period without any reminders.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universal Adherence LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Eye Institute (NEI), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Steven Mansberger, MD, MPH, Principal investigator, U n i v e r s a l A d h e r e n c e , L L CRobert Kinast, MD, Principal investigator, U n i v e r s a l A d h e r e n c e , L L CBrian Breiling, MS, BS, Principal investigator, U n i v e r s a l A d h e r e n c e , L L CVince O'Malley, Principal investigator, U n i v e r s a l A d h e r e n c e , L L C
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664943
- Sponsor's protocol ID
- 1904978
- Other IDs
- 1R44EY037603-01
- Status last verified
- Jun 2026
- First submitted
- 19 May 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The iD2: A Smart Eye Drop Cap Monitor for Eye Drop Adherence
- ClinicalTrials.gov ID
- NCT07664943
- Acronym / sponsor ID
- 1904978
- Conditions
- Glaucoma, Medication Adherence
- Keywords
- iD2, Adherence, Medication, Glaucoma, Device
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universal Adherence LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Eye Institute (NEI), National Institutes of Health (NIH)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 24 Jun 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.
Most patients with glaucoma use eye drops to lower their intraocular pressure. However, poor adherence to prescribed eye drop regimens can lead to significant loss of vision-related quality of life. This study will test the iDrop Device (iD2), a device-on-cap electronic platform monitor designed to accurately track when a research participant removes an eye drop bottle cap, wirelessly communicate usage data to a database accessible to researchers, and send on-demand alerts when a medication is due. A device capable of tracking eye drop usage and sending dosage alerts will test the hypothesis that electronic reminders improve medication adherence and help research subjects improve their eye drop taking behavior. While our primary focus is on glaucoma adherence, this device could also benefit those with other chronic eye conditions requiring regular eye drop treatment, such as dry eye, corneal endothelial disease, eye infections, and uveitis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The trial includes 4 stages: Stage 1) a 30-day run-in period using the iD2 smart cap monitor without any reminders; Stage 2) a 45-day period with 1:1 random assignment to determine the effect of no reminders vs. smart cap reminders if the drop is not used within the designated time window; Stage 3) A 45-day period in which all participants receive the reminders; and Stage 4) A 30-day period without any reminders.
| Arm | Type | Receives |
|---|---|---|
| Reminders during Stage 2 of study | Experimental | Device: Eye drop cap monitorStage 2 of the study is a 45-day period with 1:1 random assignment to determine the effect of no reminders vs. smart cap reminders if the drop is not used within the designated time window. This arm will receive smart cap reminders. |
| No reminders during Stage 2 of study | No intervention | –Stage 2 of the study is a 45-day period with 1:1 random assignment to determine the effect of no reminders vs. smart cap reminders if the drop is not used within the designated time window. This arm will not receive smart cap reminders. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18
- Taking at least one glaucoma drop daily
- A history of poor adherence when taking glaucoma eye drops. This is determined as an answer of 80% or less for the following question: "Over the past month, what percentage of your drops do you think you took correctly?"
- Owns a functioning smart phone with Bluetooth and cellular connectivity
Key exclusion criteria (2 listed)
- Advanced cognitive impairment
- Current or expected pregnancy during the study.
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 |
|---|---|---|
| Eye drop cap monitorAlso: iD2, iDrop DeviceEye drop cap monitor for improving adherence | Device | Reminders during Stage 2 of study |
Primary outcome
Change in Adherence when Using the Dose Monitor
Time frame: 150 days
The iD2 device will track when the bottle cap is removed as a measure of medication adherence. Adherence will be measured throughout the study, comparing adherence when dose reminders are given against when no dose reminders are given.
1 secondary outcome
Participant Satisfaction with the Dose Monitor
Time frame: 150 days
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 24 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Steven Mansberger, MD, MPH principal investigator
U n i v e r s a l A d h e r e n c e , L L C
Robert Kinast, MD principal investigator
U n i v e r s a l A d h e r e n c e , L L C
Brian Breiling, MS, BS principal investigator
U n i v e r s a l A d h e r e n c e , L L C
Questions about this trial
What is this clinical trial studying?
A study testing Eye drop cap monitor in people with Glaucoma and Medication Adherence, run by Universal Adherence LLC.
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 4 inclusion and 2 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 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Steven Mansberger, MD, MPH (503-413-8495, clinicaltrials@deverseye.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Adherence when Using the Dose Monitor (time frame: 150 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 24 Jun 2026.