Clinical trial NCT02031380: iDropper Usability in Glaucoma
Official title: Improving Ophthalmic Medication Adherence
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Glaucoma, Open-Angle [C11.525.381.407]
Keywords: Glaucoma
Open angle glaucoma
ocular hypertension
compliance
Lead sponsor: Care Team Solutions
Sponsor class: INDUSTRY
Collaborators: name: National Eye Institute (NEI)
First posted: 2014-01-09
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Usability questionnaire
timeFrame: 4 weeks after trial start
Secondary outcomes:
measure: Satisfaction questionnaire
timeFrame: 4 weeks after study start
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: Care Team Solutions
name: Michael Bailey, PhD
role: STUDY_DIRECTOR
affiliation: The University of Texas Health Science Center at San Antonio
name: Steven Chalfin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Congdon N, O'Colmain B, Klaver CC, Klein R, Munoz B, Friedman DS, Kempen J, Taylor HR, Mitchell P; Eye Diseases Prevalence Research Group. Causes and prevalence of visual impairment among adults in the United States. Arch Ophthalmol. 2004 Apr;122(4):477-85. doi: 10.1001/archopht.122.4.477.
citation: Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.