iDropper Usability in Glaucoma | NCT02031380

Studies
iDropper Usability in Glaucoma

NCT02031380

Sponsor

Care Team Solutions

Status

Withdrawn

Last Update Posted

Dec 8, 2015Estimated

Enrollment

0Actual

Phase

Phase 1

Conditions

Glaucoma, Open-Angle [C11.525.381.407]

Interventions

Open angle glaucoma - iDropper device

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R43EY023122-01A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Jan 7, 2014

First Submission Date that Met QC Criteria

Jan 8, 2014

First Posted Date

Jan 9, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2015

Last Update Posted Date

Dec 8, 2015Estimated

Name	Class
National Eye Institute (NEI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

At study conclusion usability and satisfaction assessments will be performed to evaluate iDropper system performance.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Open angle glaucoma - iDropper device	Experimental	Device	Device: Open angle glaucoma - iDropper device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Open angle glaucoma - iDropper device	Device	The iDropper system is an eye drop dispensing device and medication monitor designed to optimize adherence behaviors for glaucoma patients.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Bailey, PhD	Care Team Solutions	Study Director
Steven Chalfin, MD	The University of Texas Health Science Center at San Antonio	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Texas Health Science Center at San Antonio		San Antonio	Texas	78229	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15078664	Background	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.
16488940	Background	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.

ID	Term
D005901	Glaucoma
D005902	Glaucoma, Open-Angle
D009798	Ocular Hypertension
D010349	Patient Compliance

ID	Term
D005128	Eye Diseases
D010342	Patient Acceptance of Health Care
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior