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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

Tracking Information
First Submitted Date  ICMJE August 7, 2016
First Posted Date  ICMJE August 16, 2016
Results First Submitted Date  ICMJE December 11, 2018
Results First Posted Date  ICMJE February 15, 2019
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE March 23, 2017
Actual Primary Completion Date March 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 13, 2016)
Intraocular pressure change as measured by goldmann applanation when using drop aids [ Time Frame: up to 6 weeks ]
This study will measure the intraocular pressure change by applanation in patients using designated glaucoma drops aids. The intraocular pressure, which is a routine part of the ophthalmologic exam, will be measured prior to starting drop aid use and at the six week mark while using drop aids. These intraocular pressures will be compared to controls.
Change History Complete list of historical versions of study NCT02867995 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2019)
  • 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.
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2016)
  • Length of time until completion of topical ophthalmic drug bottle measured in days by the patient and will be compared between groups. [ Time Frame: up to 6 weeks ]
    Participants will record the number of days taken to complete the glaucoma medication bottle while using the drop aid
  • Patient's satisfaction in the intervention groups will be measured with a survey [ Time Frame: up to 6 weeks ]
    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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Glaucoma Drop Aids in Medication Compliance in the Patient Population at Boston Medical Center
Official Title  ICMJE Efficacy of Glaucoma Drop Aids in Medication Compliance in the Patient Population at 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).
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE Glaucoma
Intervention  ICMJE Device: Eye Drop Aid
Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, and the Simply Touch Eye Drop Applicator
Study Arms  ICMJE
  • 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)
    Intervention: Device: Eye Drop Aid
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2019)
39
Original Estimated Enrollment  ICMJE
 (submitted: August 13, 2016)
50
Actual Study Completion Date  ICMJE March 30, 2018
Actual Primary Completion Date March 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02867995
Other Study ID Numbers  ICMJE H-34905
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Manishi Desai, Boston Medical Center
Study Sponsor  ICMJE Boston Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Manishi Desai, MD Boston Medical Center
Principal Investigator: Haben Kefella, MD Boston Medical Center
Principal Investigator: Avni Badami, MD Boston Medical Center
PRS Account Boston Medical Center
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP