iDropper Usability in Glaucoma
Primary Purpose
Glaucoma, Open-Angle [C11.525.381.407]
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Open angle glaucoma - iDropper device
Sponsored by
About this trial
This is an interventional supportive care trial for Glaucoma, Open-Angle [C11.525.381.407] focused on measuring Glaucoma, Open angle glaucoma, ocular hypertension, compliance
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.
Sites / Locations
- University of Texas Health Science Center at San Antonio
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open angle glaucoma - iDropper device
Arm Description
Device
Outcomes
Primary Outcome Measures
Usability questionnaire
Written questionnaire assessing usability of the iDropper system by participants
Secondary Outcome Measures
Satisfaction questionnaire
Questionnaire assessing participant satisfaction with features of the iDropper system.
Full Information
NCT ID
NCT02031380
First Posted
January 7, 2014
Last Updated
December 6, 2015
Sponsor
Care Team Solutions
Collaborators
National Eye Institute (NEI)
1. Study Identification
Unique Protocol Identification Number
NCT02031380
Brief Title
iDropper Usability in Glaucoma
Official Title
Improving Ophthalmic Medication Adherence
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Funding
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Care Team Solutions
Collaborators
National Eye Institute (NEI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle [C11.525.381.407]
Keywords
Glaucoma, Open angle glaucoma, ocular hypertension, compliance
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open angle glaucoma - iDropper device
Arm Type
Experimental
Arm Description
Device
Intervention Type
Device
Intervention Name(s)
Open angle glaucoma - iDropper device
Intervention Description
The iDropper system is an eye drop dispensing device and medication monitor designed to optimize adherence behaviors for glaucoma patients.
Primary Outcome Measure Information:
Title
Usability questionnaire
Description
Written questionnaire assessing usability of the iDropper system by participants
Time Frame
4 weeks after trial start
Secondary Outcome Measure Information:
Title
Satisfaction questionnaire
Description
Questionnaire assessing participant satisfaction with features of the iDropper system.
Time Frame
4 weeks after study start
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Bailey, PhD
Organizational Affiliation
Care Team Solutions
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Steven Chalfin, MD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15078664
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.
Results Reference
background
PubMed Identifier
16488940
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.
Results Reference
background
Learn more about this trial
iDropper Usability in Glaucoma
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