Clinical trial NCT02867995: Efficacy of Glaucoma Drop Aids in Medication Compliance in the Patient Population at Boston Medical Center
Official title: Efficacy of Glaucoma Drop Aids in Medication Compliance in the Patient Population at Boston Medical Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: glaucoma drop aid
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Assessed for Intraocular Pressure Change
timeFrame: baseline and 6 weeks
Secondary outcomes:
measure: Number of Participants Stratified by the Number of Times Eye Was Missed When Inserting Eye Drops
timeFrame: 6 weeks
measure: Satisfaction With Eye Drop Aid
timeFrame: 6 weeks
measure: Intent to Use Eye Drop Aid Long Term
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Manishi Desai, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Medical Center
name: Haben Kefella, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Medical Center
name: Avni Badami, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Ghate D, Edelhauser HF. Barriers to glaucoma drug delivery. J Glaucoma. 2008 Mar;17(2):147-56. doi: 10.1097/IJG.0b013e31814b990d.
citation: Rivers PH. Compliance aids--do they work? Drugs Aging. 1992 Mar-Apr;2(2):103-11. doi: 10.2165/00002512-199202020-00004.