Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

iDropper Usability in Glaucoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02031380
Recruitment Status : Withdrawn (Funding)
First Posted : January 9, 2014
Last Update Posted : December 8, 2015
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Care Team Solutions

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.

Condition or disease Intervention/treatment Phase
Glaucoma, Open-Angle [C11.525.381.407] Device: Open angle glaucoma - iDropper device Phase 1

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Improving Ophthalmic Medication Adherence
Study Start Date : April 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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.




Primary Outcome Measures :
  1. Usability questionnaire [ Time Frame: 4 weeks after trial start ]
    Written questionnaire assessing usability of the iDropper system by participants


Secondary Outcome Measures :
  1. Satisfaction questionnaire [ Time Frame: 4 weeks after study start ]
    Questionnaire assessing participant satisfaction with features of the iDropper system.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02031380


Locations
Layout table for location information
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Care Team Solutions
National Eye Institute (NEI)
Investigators
Layout table for investigator information
Study Director: Michael Bailey, PhD Care Team Solutions
Principal Investigator: Steven Chalfin, MD The University of Texas Health Science Center at San Antonio

Publications:
Layout table for additonal information
Responsible Party: Care Team Solutions
ClinicalTrials.gov Identifier: NCT02031380     History of Changes
Other Study ID Numbers: 1R43EY023122-01A1-1
1R43EY023122-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: December 2015

Keywords provided by Care Team Solutions:
Glaucoma
Open angle glaucoma
ocular hypertension
compliance

Additional relevant MeSH terms:
Layout table for MeSH terms
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases