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

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ClinicalTrials.gov Identifier: NCT03506568
Recruitment Status : Completed
First Posted : April 24, 2018
Last Update Posted : June 29, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Oregon State University
National Eye Institute (NEI)
Information provided by (Responsible Party):
Universal Adherence LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Medication Adherence Glaucoma Device: Devers Drop Device (D3) app Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Universal Eye Drop Adherence Monitor to Measure and Improve Adherence to Ocular Medications
Actual Study Start Date : October 2, 2020
Actual Primary Completion Date : June 4, 2021
Actual Study Completion Date : June 4, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma Medicines

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control - no reminder
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
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
A universal eye drop cap monitor that accurately measures and improves eye drop-taking behavior.


Outcome Measures
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Primary Outcome Measures :
  1. Compliance percentage [ Time Frame: 50 days ]
    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 :
  1. Patient Satisfaction [ Time Frame: 50 days ]
    The investigators will also measure the participants' satisfaction with the dose monitor using a short Likert questionnaire. The questionnaire will include 10 questions. Each question will offer choices 1-5 with an overall minimum summed score of 10 and a maximum summed score of 50. Higher score will indicate higher satisfaction.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506568


Locations
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United States, Oregon
Robert Kinast
Portland, Oregon, United States, 97210
Sponsors and Collaborators
Universal Adherence LLC
National Institutes of Health (NIH)
Oregon State University
National Eye Institute (NEI)
Investigators
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Principal Investigator: Steve L Mansberger, MD Universal Adherence LLC
Principal Investigator: David Porter, PhD Oregon State University
More Information
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Responsible Party: Universal Adherence LLC
ClinicalTrials.gov Identifier: NCT03506568    
Other Study ID Numbers: UniversalAdherence
1R41EY028807-01 ( U.S. NIH Grant/Contract )
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: June 29, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will only be shared internally with co-investigators and those performing analysis of data.

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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
Keywords provided by Universal Adherence LLC:
Adherence
Medication
Glaucoma
Device
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases