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

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ClinicalTrials.gov Identifier: NCT02867995
Recruitment Status : Completed
First Posted : August 16, 2016
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Manishi Desai, Boston Medical Center

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).

Condition or disease Intervention/treatment Phase
Glaucoma Device: Eye Drop Aid Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Efficacy of Glaucoma Drop Aids in Medication Compliance in the Patient Population at Boston Medical Center
Actual Study Start Date : March 23, 2017
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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




Primary Outcome Measures :
  1. Number of Participants Assessed for Intraocular Pressure Change [ Time Frame: baseline and 6 weeks ]
    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.


Secondary Outcome Measures :
  1. Number of Participants Stratified by the Number of Times Eye Was Missed When Inserting Eye Drops [ Time Frame: 6 weeks ]
    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.

  2. Satisfaction With Eye Drop Aid [ Time Frame: 6 weeks ]
    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).

  3. Intent to Use Eye Drop Aid Long Term [ Time Frame: 6 weeks ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02867995


Locations
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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
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Principal Investigator: Manishi Desai, MD Boston Medical Center
Principal Investigator: Haben Kefella, MD Boston Medical Center
Principal Investigator: Avni Badami, MD Boston Medical Center
  Study Documents (Full-Text)

Documents provided by Manishi Desai, Boston Medical Center:

Publications:
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Responsible Party: Manishi Desai, Faculty Sponsor, Boston Medical Center
ClinicalTrials.gov Identifier: NCT02867995     History of Changes
Other Study ID Numbers: H-34905
First Posted: August 16, 2016    Key Record Dates
Results First Posted: February 15, 2019
Last Update Posted: February 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Manishi Desai, Boston Medical Center:
glaucoma drop aid
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions