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

Primary Purpose

Medication Adherence, Glaucoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Devers Drop Device (D3) app
Sponsored by
Universal Adherence LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Medication Adherence focused on measuring Adherence, Medication, Glaucoma, Device

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Robert Kinast

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control - no reminder

Integrated daily reminder using the D3 app

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
April 14, 2018
Last Updated
February 17, 2023
Sponsor
Universal Adherence LLC
Collaborators
National Institutes of Health (NIH), Oregon State University, National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT03506568
Brief Title
A Universal Eye Drop Adherence Monitor to Measure and Improve Adherence to Ocular Medications
Official Title
A Universal Eye Drop Adherence Monitor to Measure and Improve Adherence to Ocular Medications
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 2, 2020 (Actual)
Primary Completion Date
June 4, 2021 (Actual)
Study Completion Date
June 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universal Adherence LLC
Collaborators
National Institutes of Health (NIH), Oregon State University, National Eye Institute (NEI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Adherence, Glaucoma
Keywords
Adherence, Medication, Glaucoma, Device

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control - no reminder
Arm Type
No Intervention
Arm Description
For Group 1, there will be no changes to their instructions or smart phone, which is the most common clinical situation.
Arm Title
Integrated daily reminder using the D3 app
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Devers Drop Device (D3) app
Intervention Description
A universal eye drop cap monitor that accurately measures and improves eye drop-taking behavior.
Primary Outcome Measure Information:
Title
Compliance Percentage
Description
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
Time Frame
50 days
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Description
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.
Time Frame
50 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve L Mansberger, MD
Organizational Affiliation
Universal Adherence LLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Porter, PhD
Organizational Affiliation
Oregon State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert Kinast
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will only be shared internally with co-investigators and those performing analysis of data.

Learn more about this trial

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

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