Eye Drop Dispensers: Safety, Efficacy and Comfort.
1 other identifier
interventional
50
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2019
Shorter than P25 for not_applicable
1 active site
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
CompletedFirst Posted
Study publicly available on registry
January 31, 2018
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedMay 1, 2018
April 1, 2018
9 months
January 7, 2018
April 30, 2018
Conditions
Keywords
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 COMPARATORsubject will assess TYPE 1 dispenser
Eye Drop Dispenser Autodrop
ACTIVE COMPARATORsubject will assess Autodrop dispenser
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.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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