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

Sponsor
Universal Adherence LLC
Study ID
NCT07664943
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Eye drop cap monitor — DEVICE
    Eye drop cap monitor for improving adherence

Study Details

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.

Key Dates

First listed
Jun 24, 2026
Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • 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.
  • 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.

Primary Outcome Measure

Change in Adherence when Using the Dose Monitor [ Time Frame: 150 days ]

Central Contacts

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