iDropper Usability in Glaucoma



Status:Withdrawn
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:21 - 85
Updated:4/21/2016
Start Date:April 2014
End Date:December 2014

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Improving Ophthalmic Medication Adherence

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.

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.

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.
We found this trial at
1
site
4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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San Antonio, TX
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