NCT02867995

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

March 23, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
11 months until next milestone

Results Posted

Study results publicly available

February 15, 2019

Completed
Last Updated

February 15, 2019

Status Verified

January 1, 2019

Enrollment Period

1 year

First QC Date

August 7, 2016

Results QC Date

December 11, 2018

Last Update Submit

January 24, 2019

Conditions

Glaucoma

Keywords

glaucoma drop aid

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Number of Participants Stratified by the Number of Times Eye Was Missed When Inserting Eye Drops

    6 weeks

  • Satisfaction With Eye Drop Aid

    6 weeks

  • Intent to Use Eye Drop Aid Long Term

    6 weeks

Study Arms (2)

Control

NO INTERVENTION

No glaucoma drop aid control

Eye Drop Aids

ACTIVE COMPARATOR

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

Interventions

Eye Drop AidDEVICE

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

Eye Drop Aids

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (3)

  • 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.

    PMID: 16049530BACKGROUND

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

    PMID: 18344762BACKGROUND

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

    PMID: 1596593BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Results Point of Contact

Title
Dr. Manishi Desai
Organization
Boston Medical Center
Manishi.Desai@bmc.org
671-414-8806

Study Officials

  • Manishi Desai, MD

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

  • Haben Kefella, MD

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

  • Avni Badami, MD

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty Sponsor

Study Record Dates

First Submitted

August 7, 2016

First Posted

August 16, 2016

Study Start

March 23, 2017

Primary Completion

March 30, 2018

Study Completion

March 30, 2018

Last Updated

February 15, 2019

Results First Posted

February 15, 2019

Record last verified: 2019-01

Locations

US(1)