Eye Drop Dispensers: Safety, Efficacy and Comfort.

April 30, 2018 updated by: Asaf Achiron, Wolfson Medical Center

One aspect to eye drop adherence is successful instillation of the drops; however, it is well known that many patients struggle with this task. Difficulties may include aiming their drops,extending their neck, preventing excess drop leakage, avoiding contamination of the bottle tip and generating enough force to expel a drop from the bottle. Instillation aids are devices that aim to ameliorate one or more of these barriers.

Several eye drop dispensers had been developed in order to improved outcomes of eye drop instillation, including improved rates of successful administration and increased patient satisfaction compared to standard eye drop bottles.

In this study we aim to compare the eye drops various installation aids

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

subject will evaluate 2 dispensers by questioners. efficacy and safety of each one will be evaluated.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • glaucoma patients

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Eye Drop Dispenser TYPE Opticare
subject will assess TYPE 1 dispenser
Device: Eye Drop Dispenser TYPE Opticare

Subject will apply normal saline eye drops to them-self with various eye drop dispensers.

Assessment of ease of use will be conducted by questioners.
Active Comparator: Eye Drop Dispenser Autodrop
subject will assess Autodrop dispenser
Device: Eye Drop Dispenser Autodrop
Eye Drop Dispenser Autodrop

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of correct application of eye drops to the eye without missing conducted by questioners.
Time Frame: 5 seconds after instillation of eye drops
assessment of correct application of eye drops to the eye without missing
5 seconds after instillation of eye drops

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wolfson Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2019

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

January 7, 2018

First Submitted That Met QC Criteria

January 24, 2018

First Posted (Actual)

January 31, 2018

Study Record Updates

Last Update Posted (Actual)

May 1, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Eye Drop Dispensers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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