Efficacy of Glaucoma Drop Aids in Medication Compliance in the Patient Population at Boston Medical Center

The purpose of this study is to determine whether glaucoma drop aids will be cost-effective in delivery of ophthalmic medications by improving medication compliance, visual function, and even decreasing medication waste in the patient population at Boston Medical Center (BMC).

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Device: Eye Drop Aid

Detailed Description

Patients being treated for their glaucoma at BMC's Yawkey Eye Clinic will be selected according to the inclusion and exclusion criteria. The three drop aids used in this study will be the Fabrication Autodrop Eye Drop Guide, Owen Mumford OP 6100 Autosqueeze, and the Simply Touch Eye Drop Applicator. Patients will be randomly placed on one of these drops aids for a total of 3 study groups or the no drop aid control, for a total of 4 groups. Prior to use of the drop aid, patients will be instructed on how to use the drop aid by a resident physician and a pre- intervention intraocular pressure check will be performed by the resident physician using an applicator. Intraocular pressure is the only adjustable risk factor for glaucoma; thus, glaucoma treatments slow progression of glaucoma by reducing intraocular pressure. In addition, patients will be requested to deliver their drops with the drop aid with every use. Furthermore, each patient will record the number of days taken to complete the glaucoma medication bottle while using the drop aid. At the 3 and 6 week marks, the patient will fill out a satisfaction survey. Patients will need to return to the clinic at the 6 week mark and can fill out the satisfaction survey at the clinic in addition to checking the intraocular pressure post-intervention. Thus, the number of subject contact will be two, pre and post-intervention, the duration of participation for each subject will be 6 weeks, and the patient will also be required to fill out two satisfaction surveys. The effectiveness of the drop aids will be compared to the two controls and measured with any changes in intraocular pressure readings, length of time to medication completion, and patient satisfaction according to the surveys.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age 18 years or greater
• Currently on the same topical medication for treatment of glaucoma for a minimum of two months
• Patient of Boston University eye Associates
• Agrees to use the drop aid with each delivery, return to the clinic after 6 weeks of using the drop aid, document completion of medication drops and fill out survey at the end of the 6 weeks

Exclusion Criteria:

• Less than age 18 years
• Changes glaucoma medication within the past two month or recent glaucoma surgery
• Older than 89 years of age
• Not a patient of the Boston University eye associate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; No glaucoma drop aid control
ACTIVE_COMPARATOR: Eye Drop Aids; Participants could be placed into one of the drop aid groups (Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, or the Simply Touch Eye Drop Applicator)	Device: Eye Drop Aid; Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, and the Simply Touch Eye Drop Applicator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Assessed for Intraocular Pressure Change	Intraocular pressure (IOP) is measured by Goldman applanation in patients and is expressed in mmHg. The IOP, which is a routine check in the ophthalmic exam, was measured in the eye drop aid group prior to starting drop aid use and at six weeks while using drop aids. IOP was measured at baseline and at 6 weeks in the control group. A significant increase in IOP is defined as an increase of 4 mmHg or more, a significant decreases in IOP is defined as a decrease of 4mmHg or more. No significant change in the IOP is a change between 1-3 mmHg.	baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Stratified by the Number of Times Eye Was Missed When Inserting Eye Drops	A question on the six week survey asked approximately how often the participant missed their eye when inserting eye drops. Response options included: missed inserting eye drops 0 times, missed inserting eye drops 1 time, missed inserting eye drops 2 times, or missed inserting eye drops 3 or more times.	6 weeks
Satisfaction With Eye Drop Aid	A question on the six week survey asked if the participant liked the eye drop aid. Response options included: liked the drop aid long term, did not like the drop aid, or did not use a drop aid. Results were stratified by the three drop aid types (Fabrication Autodrop Eye Drop Guide, Owen Mumford OP 6100 Autosqueeze, or the Simply Touch Eye Drop Applicator).	6 weeks
Intent to Use Eye Drop Aid Long Term	A question on the six week survey asked if the participant intended to use the eye drop aid long term. Response options included: would use the drop aid long term, would not use the drop aid long term, or did not use a drop aid. Results were stratified by the three drop aid types (Fabrication Autodrop Eye Drop Guide, Owen Mumford OP 6100 Autosqueeze, or the Simply Touch Eye Drop Applicator).	6 weeks

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Investigators: Principal Investigator: Manishi Desai, MD, Boston Medical Center; Principal Investigator: Haben Kefella, MD, Boston Medical Center; Principal Investigator: Avni Badami, MD, Boston Medical Center

Publications and helpful links

General Publications

• Salyani A, Birt C. Evaluation of an eye drop guide to aid self-administration by patients experienced with topical use of glaucoma medication. Can J Ophthalmol. 2005 Apr;40(2):170-4. doi: 10.1016/S0008-4182(05)80028-6.
• Ghate D, Edelhauser HF. Barriers to glaucoma drug delivery. J Glaucoma. 2008 Mar;17(2):147-56. doi: 10.1097/IJG.0b013e31814b990d.
• Rivers PH. Compliance aids--do they work? Drugs Aging. 1992 Mar-Apr;2(2):103-11. doi: 10.2165/00002512-199202020-00004.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 23, 2017
• Primary Completion (ACTUAL): March 30, 2018
• Study Completion (ACTUAL): March 30, 2018

Study Registration Dates

• First Submitted: August 7, 2016
• First Submitted That Met QC Criteria: August 13, 2016
• First Posted (ESTIMATE): August 16, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 15, 2019
• Last Update Submitted That Met QC Criteria: January 24, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: glaucoma drop aid
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: H-34905

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No