Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2014-04-30
2014-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Cognitive or visual impairment that would interfere with completing a self-administered questionnaire.
21 Years
85 Years
ALL
No
Sponsors
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National Eye Institute (NEI)
NIH
Care Team Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Bailey, PhD
Role: STUDY_DIRECTOR
Care Team Solutions
Steven Chalfin, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Locations
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University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Countries
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References
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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.
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.
Other Identifiers
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1R43EY023122-01A1-1
Identifier Type: -
Identifier Source: org_study_id