iDropper Usability in Glaucoma
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|ClinicalTrials.gov Identifier: NCT02031380|
Recruitment Status : Withdrawn (Funding)
First Posted : January 9, 2014
Last Update Posted : December 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma, Open-Angle [C11.525.381.407]||Device: Open angle glaucoma - iDropper device||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Improving Ophthalmic Medication Adherence|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Experimental: Open angle glaucoma - iDropper device
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.
- Usability questionnaire [ Time Frame: 4 weeks after trial start ]Written questionnaire assessing usability of the iDropper system by participants
- Satisfaction questionnaire [ Time Frame: 4 weeks after study start ]Questionnaire assessing participant satisfaction with features of the iDropper system.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02031380
|United States, Texas|
|University of Texas Health Science Center at San Antonio|
|San Antonio, Texas, United States, 78229|
|Study Director:||Michael Bailey, PhD||Care Team Solutions|
|Principal Investigator:||Steven Chalfin, MD||The University of Texas Health Science Center at San Antonio|