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

NCT ID: NCT02867995

Last Updated: 2019-02-15

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-23

Study Completion Date

2018-03-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

No glaucoma drop aid control

Group Type NO_INTERVENTION

No interventions assigned to this group

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)

Group Type ACTIVE_COMPARATOR

Eye Drop Aid

Intervention Type DEVICE

Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, and the Simply Touch Eye Drop Applicator

Interventions

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Eye Drop Aid

Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, and the Simply Touch Eye Drop Applicator

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Manishi Desai

Faculty Sponsor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manishi Desai, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Haben Kefella, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Avni Badami, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

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Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16049530 (View on PubMed)

Ghate D, Edelhauser HF. Barriers to glaucoma drug delivery. J Glaucoma. 2008 Mar;17(2):147-56. doi: 10.1097/IJG.0b013e31814b990d.

Reference Type BACKGROUND
PMID: 18344762 (View on PubMed)

Rivers PH. Compliance aids--do they work? Drugs Aging. 1992 Mar-Apr;2(2):103-11. doi: 10.2165/00002512-199202020-00004.

Reference Type BACKGROUND
PMID: 1596593 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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H-34905

Identifier Type: -

Identifier Source: org_study_id

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