iDropper Usability in Glaucoma

Glaucoma, Open-Angle [C11.525.381.407] Clinical Trial

Official title:

Improving Ophthalmic Medication Adherence

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02031380
• Other study ID #: 1R43EY023122-01A1-1
• Secondary ID: 1R43EY023122-01A
• Status: Withdrawn
• Phase: Phase 1
• First received: January 7, 2014
• Last updated: December 6, 2015
• Start date: April 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2015
• Source: Care Team Solutions
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 85 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Glaucoma, Open-Angle [C11.525.381.407]

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Care Team Solutions	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Congdon N, O'Colmain B, Klaver CC, Klein R, Muñoz 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usability questionnaire	Written questionnaire assessing usability of the iDropper system by participants	4 weeks after trial start	No
Secondary	Satisfaction questionnaire	Questionnaire assessing participant satisfaction with features of the iDropper system.	4 weeks after study start	No