A Universal Eye Drop Adherence Monitor to Measure and Improve Adherence to Ocular Medications

Glaucoma Clinical Trial

Official title:

A Universal Eye Drop Adherence Monitor to Measure and Improve Adherence to Ocular Medications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03506568
• Other study ID #: UniversalAdherence
• Secondary ID: 1R41EY028807-01
• Status: Completed
• Phase: N/A
• Start date: October 2, 2020
• Est. completion date: June 4, 2021

Study information

• Verified date: February 2023
• Source: Universal Adherence LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Glaucoma is the second leading cause of visual impairment worldwide. Eye drop medications reduce vision loss from glaucoma by at least 60%, but eye drops must be taken every day to be effective. However, adherence to eye drop treatment is poor with only 50% of patients regularly taking their prescribed eye drops. The investigators are developing the Devers Drop Device (D3) eye drop monitor to accurately measure eye drop cap removal and to improve eye drop-taking behavior. The investigators will test eye drop adherence with the D3 device in a randomized, prospective clinical trial.

Description:

Universal Adherence is an emerging medical device company dedicated to improving adherence to ocular medications through innovative technical solutions. The Devers Drop Device (D3) will accurately track when a patient removes an eye drop bottle cap, communicate usage data wirelessly to a database that researchers can access, and send alerts to patients when a medication is due. In addition to helping patients maintain their dosing schedule, the D3 will also provide adherence information to researchers and eye care providers, which will help to understand poor treatment outcomes and to develop improved treatment strategies.The clinical benefits of the device in improving adherence will initially be assessed and targeted towards glaucoma, but the ability of the device to be attached to all FDA-approved eye drop bottle caps will make this device attractive to all patients that need consistent daily use of eye drops.

Randomized, prospective clinical trial: The investigators will enroll 50 participants (25 male, 25 female) into a prospective trial with duration of up to 50 days. The inclusion criteria are those who are prescribed latanoprost eye drop to be used once per day at bedtime, and own a functioning Android or Apple iphone smartphone (iOs) with Bluetooth and cellular connectivity. The investigators will exclude patients who currently use smartphone medication reminders and those with severe cognitive impairment limiting their ability to understand a questionnaire. The 50-day period is useful for glaucoma studies because patients revert to their normal dosing pattern within two weeks after their last visit. This study will include two stages: Stage 1) a 25-day period evaluating baseline patient adherence with the D3 device; and Stage 2) a subsequent 25-day period to determine the effect of no reminder versus daily reminder using the D3 app, which includes integrated audio and visual reminders.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 4, 2021
• Est. primary completion date: June 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who are prescribed latanoprost eye drop to be used once per day at bedtime, and own a functioning smartphone and have a password-protected home wireless connection.

Exclusion Criteria:

• Patients who currently use smartphone medication reminders and those with severe cognitive impairment limiting their ability to understand a questionnaire.

Related Conditions & MeSH terms

• Glaucoma
• Medication Adherence

Intervention

Device:
• Devers Drop Device (D3) app
A universal eye drop cap monitor that accurately measures and improves eye drop-taking behavior.

Locations

Country	Name	City	State
United States	Robert Kinast	Portland	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
Universal Adherence LLC	National Eye Institute (NEI), National Institutes of Health (NIH), Oregon State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance Percentage	Compliance percentage by dividing the number of days the dose monitor recorded dosing within 3 hours of the prescribed time by the number of days in the study cycle	50 days
Secondary	Patient Satisfaction	The investigators will also measure the participants' satisfaction with the dose monitor using a short Likert questionnaire. The questionnaire will include 5 questions. Each question will offer choices 1-5 with an overall minimum summed score of 5 and a maximum summed score of 25. Higher score will indicate higher satisfaction.	50 days