Viewing Study NCT03506568



Ignite Creation Date: 2024-05-06 @ 11:23 AM
Last Modification Date: 2024-10-26 @ 12:44 PM
Study NCT ID: NCT03506568
Status: COMPLETED
Last Update Posted: 2023-02-21
First Post: 2018-04-14

Brief Title: A Universal Eye Drop Adherence Monitor to Measure and Improve Adherence to Ocular Medications
Sponsor: Universal Adherence LLC
Organization: Universal Adherence LLC

Study Overview

Official Title: A Universal Eye Drop Adherence Monitor to Measure and Improve Adherence to Ocular Medications
Status: COMPLETED
Status Verified Date: 2023-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 strategiesThe 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: True
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
1R41EY028807-01 NIH None httpsreporternihgovquickSearch1R41EY028807-01