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NCT Number: NCT07664943

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eye drop cap monitor

Device

Eye drop cap monitor for improving adherence

Other names: iD2, iDrop Device

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Steven Mansberger, MD, MPH

CONTACT

[email protected]

503-413-8495

Sponsors and collaborators

Lead sponsor

Universal Adherence LLC

Industry

Collaborators

  • National Eye Institute (NEI)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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