Back to resultsEye Drop Dispensers: Safety, Efficacy and Comfort.
Primary Purpose
Glaucoma, Cataract, Healthy Subjects
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Eye Drop Dispenser TYPE Opticare
Eye Drop Dispenser Autodrop
Sponsored by
About this trial
This is an interventional supportive care trial for Glaucoma focused on measuring normal patients, eye drops dispensers, aids, glacuoma, cataract
Eligibility Criteria
Inclusion Criteria:
- glaucoma patients
Exclusion Criteria:
- none
Sites / Locations
- Asaf AchironRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Eye Drop Dispenser TYPE Opticare
Eye Drop Dispenser Autodrop
Arm Description
subject will assess TYPE 1 dispenser
subject will assess Autodrop dispenser
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03417453
Brief Title
Eye Drop Dispensers: Safety, Efficacy and Comfort.
Official Title
Eye Drop Dispensers: Safety, Efficacy and Comfort.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Anticipated)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wolfson Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
Detailed Description
subject will evaluate 2 dispensers by questioners. efficacy and safety of each one will be evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Cataract, Healthy Subjects
Keywords
normal patients, eye drops dispensers, aids, glacuoma, cataract
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Eye Drop Dispenser TYPE Opticare
Arm Type
Active Comparator
Arm Description
subject will assess TYPE 1 dispenser
Arm Title
Eye Drop Dispenser Autodrop
Arm Type
Active Comparator
Arm Description
subject will assess Autodrop dispenser
Intervention Type
Device
Intervention Name(s)
Eye Drop Dispenser TYPE Opticare
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Eye Drop Dispenser Autodrop
Intervention Description
Eye Drop Dispenser Autodrop
Primary Outcome Measure Information:
Title
Number of correct application of eye drops to the eye without missing conducted by questioners.
Description
assessment of correct application of eye drops to the eye without missing
Time Frame
5 seconds after instillation of eye drops
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
glaucoma patients
Exclusion Criteria:
none
Facility Information:
Facility Name
Asaf Achiron
City
Tel-aviv
ZIP/Postal Code
64512
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
asaf Achiron, MD
Phone
524853549
Email
achironasaf@gmail.com
First Name & Middle Initial & Last Name & Degree
Keren
Phone
+97235035713
Email
achironasaf@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Eye Drop Dispensers: Safety, Efficacy and Comfort.
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