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

NCT ID: NCT03506568

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-02
• Study Completion Date: 2021-06-04

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.

Detailed 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.

Conditions

Medication Adherence; Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Control - no reminder

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Integrated daily reminder using the D3 app

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.

Group Type: EXPERIMENTAL

Devers Drop Device (D3) app

Intervention Type: DEVICE

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

Interventions

Devers Drop Device (D3) app

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Oregon State University

OTHER

Sponsor Role: collaborator

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

Universal Adherence LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steve L Mansberger, MD

Role: PRINCIPAL_INVESTIGATOR

Universal Adherence LLC

David Porter, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon State University

Locations

Robert Kinast

Portland, Oregon, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R41EY028807-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UniversalAdherence

Identifier Type: -

Identifier Source: org_study_id