The iD2: A Smart Eye Drop Cap Monitor for Eye Drop Adherence

NCT07664943 | Not Yet Recruiting

• 2 other identifiers: 19049781R44EY037603-01
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Keywords

iD2; Adherence; Medication; Glaucoma; Device

Outcome Measures

Primary Outcomes (1)

• 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.

  150 days

Secondary Outcomes (1)

• Participant Satisfaction with the Dose Monitor

  150 days

Study Arms (2)

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.

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.

Interventions

Eye drop cap monitor DEVICE

Eye drop cap monitor for improving adherence

Also known as: iD2, iDrop Device

Reminders during Stage 2 of study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Advanced cognitive impairment
• Current or expected pregnancy during the study.

Sponsors & Collaborators

• Universal Adherence LLC: lead
• National Eye Institute (NEI): collaborator
• National Institutes of Health (NIH): collaborator

MeSH Terms

Conditions

Glaucoma; Medication Adherence

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Mansberger, MD, MPH

CONTACT

503-413-8495; clinicaltrials@deverseye.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: June 24, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share