Trial Outcomes & Findings for A Universal Eye Drop Adherence Monitor to Measure and Improve Adherence to Ocular Medications (NCT NCT03506568)
NCT ID: NCT03506568
Last Updated: 2023-02-21
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
50 days
Results posted on
2023-02-21
Participant Flow
Participant milestones
| Measure |
Control - no Reminder
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
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.
Devers Drop Device (D3) app: A universal eye drop cap monitor that accurately measures and improves eye drop-taking behavior.
|
Baseline Adherence Test
During the initial testing to determine baseline adherence to the subject's glaucoma medication. If the subject's did not take their medication at least 90% of the time, they qualified to be randomized into the other 2 groups/arms
|
|---|---|---|---|
|
Stage 1
STARTED
|
0
|
0
|
50
|
|
Stage 1
COMPLETED
|
0
|
0
|
5
|
|
Stage 1
NOT COMPLETED
|
0
|
0
|
45
|
|
Stage 2
STARTED
|
2
|
3
|
0
|
|
Stage 2
COMPLETED
|
1
|
2
|
0
|
|
Stage 2
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Universal Eye Drop Adherence Monitor to Measure and Improve Adherence to Ocular Medications
Baseline characteristics by cohort
| Measure |
Control - no Reminder
n=2 Participants
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
n=3 Participants
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.
Devers Drop Device (D3) app: A universal eye drop cap monitor that accurately measures and improves eye drop-taking behavior.
|
Baseline Adherence
n=45 Participants
Before randomizing subjects, all were given the device to observe if their adherence to their own medication was worse than 90% of the time. If so, they would enter the second stage and be placed in Group 1 or 2
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Age, Continuous
|
73.5 years
STANDARD_DEVIATION 6.36 • n=5 Participants
|
64 years
STANDARD_DEVIATION 8.88 • n=7 Participants
|
68.13 years
STANDARD_DEVIATION 11.17 • n=5 Participants
|
67.8 years
STANDARD_DEVIATION 8.75 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
45 participants
n=5 Participants
|
50 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 50 daysCompliance 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
Outcome measures
| Measure |
Integrated Daily Reminder Using the D3 App
n=2 Participants
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.
Devers Drop Device (D3) app: A universal eye drop cap monitor that accurately measures and improves eye drop-taking behavior.
|
Baseline Adherence
n=50 Participants
Anyone who was not randomized into group 1 or 2 after taking their drops at least 90% of the time
|
Control - no Reminder
n=1 Participants
For Group 1, there will be no changes to their instructions or smart phone, which is the most common clinical situation.
|
|---|---|---|---|
|
Compliance Percentage
|
94.6 percentage of days dose monitor recorded
Standard Deviation 7.6
|
93.99 percentage of days dose monitor recorded
Standard Deviation 16.2
|
73.9 percentage of days dose monitor recorded
Standard Deviation NA
Mean and Standard Deviation not available since only 1 participant was analyzed for the assessment
|
SECONDARY outcome
Timeframe: 50 daysThe 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.
Outcome measures
| Measure |
Integrated Daily Reminder Using the D3 App
n=2 Participants
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.
Devers Drop Device (D3) app: A universal eye drop cap monitor that accurately measures and improves eye drop-taking behavior.
|
Baseline Adherence
n=47 Participants
Anyone who was not randomized into group 1 or 2 after taking their drops at least 90% of the time
|
Control - no Reminder
n=1 Participants
For Group 1, there will be no changes to their instructions or smart phone, which is the most common clinical situation.
|
|---|---|---|---|
|
Patient Satisfaction
|
22.5 scores on a scale
Standard Deviation 2.1
|
22.1 scores on a scale
Standard Deviation 3.0
|
17 scores on a scale
Standard Deviation NA
Standard Deviation not available since only 1 participant was analyzed for the assessment
|
Adverse Events
Control - no Reminder
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Integrated Daily Reminder Using the D3 App
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Baseline Adherence
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control - no Reminder
n=2 participants at risk
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
n=3 participants at risk
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.
Devers Drop Device (D3) app: A universal eye drop cap monitor that accurately measures and improves eye drop-taking behavior.
|
Baseline Adherence
n=50 participants at risk
All subjects pre-randomization had the device with no reminders. If they took their eye drops at least 90% of the prescribed number of days they left the study
|
|---|---|---|---|
|
Nervous system disorders
Vertigo
|
50.0%
1/2 • Number of events 1 • 1 month
The device does not change the level of risk for someone already taking eye drops.
|
0.00%
0/3 • 1 month
The device does not change the level of risk for someone already taking eye drops.
|
0.00%
0/50 • 1 month
The device does not change the level of risk for someone already taking eye drops.
|
|
Eye disorders
Adenoviral Conjunctivitis
|
0.00%
0/2 • 1 month
The device does not change the level of risk for someone already taking eye drops.
|
0.00%
0/3 • 1 month
The device does not change the level of risk for someone already taking eye drops.
|
2.0%
1/50 • Number of events 1 • 1 month
The device does not change the level of risk for someone already taking eye drops.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place