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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversal Adherence LLC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Advanced cognitive impairment

Current or expected pregnancy during the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Eye drop cap monitor

    Device

    Eye drop cap monitor for improving adherence

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Reminders during Stage 2 of studyExperimental treatment 1 intervention
Group B: No reminders during Stage 2 of studyNo intervention 0 interventions

Trial outcomes

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.

Time frame
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.

Time frame
150 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universal Adherence LLC

Lead sponsor

National Eye Institute (NEI)

Collaborator

National Institutes of Health (NIH)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: