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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Medication Adherence, Glaucoma

Intervention / Treatment
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* Device: Devers Drop Device (D3) app


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control - no reminder<br>For Group 1, there will be no changes to their instructions or smart phone, which is the most common clinical situation. | |
| Experimental: Integrated daily reminder using the D3 app<br>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<br>* A universal eye drop cap monitor that accurately measures and improves eye drop-taking behavior.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adherence, Medication, Glaucoma, Device