The iD2: A Smart Eye Drop Cap Monitor for Eye Drop Adherence
June 17, 2026 updated by: Universal Adherence LLC
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 Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Steven Mansberger, MD, MPH
- Phone Number: 503-413-8495
- Email: clinicaltrials@deverseye.org
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Advanced cognitive impairment
- Current or expected pregnancy during the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Reminders during Stage 2 of study
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.
|
Eye drop cap monitor for improving adherence
Other Names:
|
|
No Intervention: No reminders during Stage 2 of study
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
150 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant Satisfaction with the Dose Monitor
Time Frame: 150 days
|
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.
|
150 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Steven Mansberger, MD, MPH, U n i v e r s a l A d h e r e n c e , L L C
- Principal Investigator: Robert Kinast, MD, U n i v e r s a l A d h e r e n c e , L L C
- Principal Investigator: Brian Breiling, MS, BS, U n i v e r s a l A d h e r e n c e , L L C
- Principal Investigator: Vince O'Malley, U n i v e r s a l A d h e r e n c e , L L C
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
August 31, 2027
Study Registration Dates
First Submitted
May 19, 2026
First Submitted That Met QC Criteria
June 17, 2026
First Posted (Actual)
June 24, 2026
Study Record Updates
Last Update Posted (Actual)
June 24, 2026
Last Update Submitted That Met QC Criteria
June 17, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1904978
- 1R44EY037603-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.