iDropper Usability in Glaucoma

Study Overview
=================
Brief 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.

Official Title
-----------------
Improving Ophthalmic Medication Adherence

Conditions
-----------------
Glaucoma, Open-Angle [C11.525.381.407]

Intervention / Treatment
-----------------
* Device: Open angle glaucoma - iDropper device


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open angle glaucoma - iDropper device<br>Device | Device: Open angle glaucoma - iDropper device<br>* The iDropper system is an eye drop dispensing device and medication monitor designed to optimize adherence behaviors for glaucoma patients.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability questionnaire | Written questionnaire assessing usability of the iDropper system by participants | 4 weeks after trial start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction questionnaire | Questionnaire assessing participant satisfaction with features of the iDropper system. | 4 weeks after study start | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, Open angle glaucoma, ocular hypertension, compliance