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

NCT03506568 | Completed Results DMC FDA Device

• 2 other identifiers: UniversalAdherence1R41EY028807-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Medication Adherence; Glaucoma

Keywords

Adherence; Medication; Glaucoma; Device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient Satisfaction

  50 days

Study Arms (2)

Control - no reminder

NO INTERVENTION

For Group 1, there will be no changes to their instructions or smart phone, which is the most common clinical situation.

Integrated daily reminder using the D3 app

EXPERIMENTAL

For Group 2, they will have their D3 app turned on to deliver both a push notification reminder to their smart phone and audio and visual reminders to their D3 device.

Device: Devers Drop Device (D3) app

Interventions

Devers Drop Device (D3) app DEVICE

A universal eye drop cap monitor that accurately measures and improves eye drop-taking behavior.

Integrated daily reminder using the D3 app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universal Adherence LLC: lead
• National Institutes of Health (NIH): collaborator
• Oregon State University: collaborator
• National Eye Institute (NEI): collaborator

Study Sites (1)

Robert Kinast

Portland, Oregon, 97210, United States

Location

MeSH Terms

Conditions

Medication Adherence; Glaucoma

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: Dr. Robert Kinast
• Organization: Devers Eye Institute

robertkinast@gmail.com

503-413-8202

Study Officials

• Steve L Mansberger, MD

  Universal Adherence LLC

  PRINCIPAL INVESTIGATOR

• David Porter, PhD

  Oregon State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2018
• First Posted: April 24, 2018
• Study Start: October 2, 2020
• Primary Completion: June 4, 2021
• Study Completion: June 4, 2021
• Last Updated: February 21, 2023
• Results First Posted: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)