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Not yet recruiting NCT07664943

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

No phase Interventional Glaucoma Medication Adherence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Eye drop cap monitor.
Who it may be relevant to
Registry conditions: Glaucoma, Medication Adherence. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Device Eye drop cap monitor
    Eye drop cap monitor for improving adherence

Primary outcome measures

  • Change in Adherence when Using the Dose Monitor [Time frame: 150 days]
Secondary outcome measures (1)
  • Participant Satisfaction with the Dose Monitor [Time frame: 150 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07664943 · 1904978 · 1R44EY037603-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗