iDropper Usability in Glaucoma

Improving Ophthalmic Medication Adherence

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.

Study Overview

• Status: Withdrawn
• Conditions: Glaucoma, Open-Angle [C11.525.381.407]
• Intervention / Treatment: Device: Open angle glaucoma - iDropper device

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.

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center at San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open angle glaucoma - iDropper device; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Care Team Solutions
• Collaborators: National Eye Institute (NEI)
• Investigators: Study Director: Michael Bailey, PhD, Care Team Solutions; Principal Investigator: Steven Chalfin, MD, The University of Texas Health Science Center at San Antonio

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: January 7, 2014
• First Submitted That Met QC Criteria: January 8, 2014
• First Posted (Estimate): January 9, 2014

Study Record Updates

• Last Update Posted (Estimate): December 8, 2015
• Last Update Submitted That Met QC Criteria: December 6, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: compliance; Glaucoma; ocular hypertension; Open angle glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: 1R43EY023122-01A1-1; 1R43EY023122-01A1 (U.S. NIH Grant/Contract)