NCT03417453

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
1.2 years until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

May 1, 2018

Status Verified

April 1, 2018

Enrollment Period

9 months

First QC Date

January 7, 2018

Last Update Submit

April 30, 2018

Conditions

Keywords

normal patientseye drops dispensersaidsglacuomacataract

Outcome Measures

Primary Outcomes (1)

  • Number of correct application of eye drops to the eye without missing conducted by questioners.

    assessment of correct application of eye drops to the eye without missing

    5 seconds after instillation of eye drops

Study Arms (2)

Eye Drop Dispenser TYPE Opticare

ACTIVE COMPARATOR

subject will assess TYPE 1 dispenser

Device: Eye Drop Dispenser TYPE Opticare

Eye Drop Dispenser Autodrop

ACTIVE COMPARATOR

subject will assess Autodrop dispenser

Device: Eye Drop Dispenser Autodrop

Interventions

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.

Eye Drop Dispenser TYPE Opticare

Eye Drop Dispenser Autodrop

Eye Drop Dispenser Autodrop

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • glaucoma patients

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asaf Achiron

Tel Aviv, 64512, Israel

RECRUITING

MeSH Terms

Conditions

GlaucomaCataractAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesLens DiseasesHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

January 7, 2018

First Posted

January 31, 2018

Study Start

April 1, 2019

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

May 1, 2018

Record last verified: 2018-04

Locations