iDropper Usability in Glaucoma

CareTeam Solutions

Status and phase

Withdrawn

Phase 1

Conditions

Glaucoma, Open-Angle [C11.525.381.407]

Treatments

Device: Open angle glaucoma - iDropper device

Study type

Interventional

Funder types

Industry

NIH

Identifiers

NCT02031380

1R43EY023122-01A1-1

1R43EY023122-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

At study conclusion usability and satisfaction assessments will be performed to evaluate iDropper system performance.

Sex

All

Ages

21 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

At least 21 years of age;
Physician diagnosis of: open angle glaucoma, angle-closure glaucoma, glaucoma suspect, or ocular hypertension
Responsible for self-administration of eye drops.
No surgery within the prior 3 months;
Able to speak and read English;

Exclusion criteria

Having any concurrent medical or psychiatric condition that, in the investigator's opinion, may preclude participation in this study; or
Cognitive or visual impairment that would interfere with completing a self-administered questionnaire.