NCT02031380

iDropper Usability in Glaucoma

Improving Ophthalmic Medication Adherence

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Care Team Solutions · Industry
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the usability of a medication management support system for glaucoma patients self-administering eye drops named iDropper. The iDropper system is a home-based ocular medication management system that reminds, instructs, dispenses, and records eye drop medication usage. The iDropper system will be evaluated among a cohort of glaucoma subjects self-administering eye drops for 4-weeks.

Detailed description

Glaucoma is a leading cause of vision loss in the United States, impacting the lives of \~4 million people. Left untreated or inadequately managed, it causes blindness -- the second ranking cause of blindness in the world as well as the leader among African Americans. Estimates project 79.6 million glaucoma diagnoses worldwide by 2020; of these, 74% will have open-angle glaucoma (OAG), which occurs virtually without symptoms. The explanation for such strikingly high disease prevalence and blindness rates is partially due to the asymptomatic nature of glaucoma. However, deficient adherence to glaucoma ocular hypotensive drops is a significant and escalating health care problem. Glaucoma eye drops are often the first therapeutic choice and very effective at controlling intraocular pressure (IOP) to prevent eye damage. However, glaucoma is a chronic condition and daily dosing regimens for medications can be complex and difficult to manage with impaired vision. Consequently, adherence and persistence to glaucoma eye drop regimens over time becomes quite poor. Overwhelming research brings the unwelcome conclusion that long term persistence with glaucoma medication is 33-39% at one year and positively contributes to blindness. Currently, no mechanism exists for supporting and monitoring glaucoma eye drop compliance. The purpose of this study is to evaluate the usability of a medication management support system for glaucoma patients self-administering eye drops named iDropper. The iDropper system is a home-based ocular medication management system that reminds, instructs, dispenses, and records eye drop medication usage. The iDropper system will be evaluated among a cohort of glaucoma subjects self-administering eye drops for 4-weeks. At study conclusion usability and satisfaction assessments will be performed to evaluate iDropper system performance.

Conditions

• Glaucoma, Open-Angle [C11.525.381.407]

Interventions

Type	Name	Description
DEVICE	Open angle glaucoma - iDropper device	The iDropper system is an eye drop dispensing device and medication monitor designed to optimize adherence behaviors for glaucoma patients.

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-01-09
• Last updated: 2015-12-08

Locations

1 site across 1 country: United States