Back to resultsTactile Low Vision Labeling of Ophthalmic Drops
Primary Purpose
Low Vision Aids
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tactile Labels for Drug identity and dose frequency
Sponsored by
About this trial
This is an interventional other trial for Low Vision Aids focused on measuring Low Vision, Labeling, Tactile
Eligibility Criteria
IInclusion Criteria:
Phase I:
- Candidates will be healthy adults between 18 and 100 years of age
- Candidates will complete the consent briefing and consent documents prior to participating in any study activities.
- Phase II:Inclusion Criteria:
- Candidates will be between 50 and 100 years of age.
- Candidates will have a BCVA equal to or less than 20/70 or have central vision field less than 20 degrees.
- Candidates will complete the consent briefing and consent documents prior to participating in any study activities.
Exclusion Criteria:
Phase I:
- Candidates who do not complete the consent briefing and indicate consent through completion of consent documents with or without a witness (as indicated by their ability to read the documents for themselves out loud with whatever optical assistance necessary (large print, magnification, optical correction, etc.), prior to any study activity, will not be included in this study.
- History of prior non-compliance or the presence or history of psychiatric condition (including drug or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigators instructions.
Phase II;
- Candidates under 50 years or older than 100 years of age will be excluded.
- Candidates with a BCVA better than 20/70 or have central vision field greater than 20 degrees, will be excluded.
- Candidates with comorbidities that in the opinion of the investigator confound their ability to complete the assessments in this study (ie. Advanced neuropathy of the hands, dementia, or mental incapacity) will be excluded.
- Candidates who do not complete the consent briefing and indicate consent through completion of consent documents with or without a witness (as indicated by their ability to read the documents for themselves out loud with whatever optical assistance necessary (large print, magnification, optical correction, etc.), prior to any study activity, will not be included in this study.
- History of prior non-compliance or the presence or history of psychiatric condition (including drug or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigators instructions.
Sites / Locations
- University of Texas Medical Branch, Ophthalmology Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Phase I- Visually Obscured Healthy Subjects
Phase II- Low Vision Over 50 years of age
Arm Description
Tactile label to be evaluated by healthy subjects without visual defect. Subjects in visually obscuring lenses but without peripheral neuropathies or other tactile deficits will evaluate the tactile labeling product for efficacy in drug identity and dosing definition. .
Subjects with documented Low Vision of 20/70 or less or visual field less than 20 degrees will be asked to evaluate tactile labeling product for efficacy in drug identity and dosing definition.
Outcomes
Primary Outcome Measures
Correct Drug Identity by Shape
Subjects Assessment and Report of drug identity by shape of label protrusions
Correct Drug Identity by Color
Subject Assessment and Report of drug identity by color of tactile label
Correct Dose Frequency by Tactile Protrusions
Subject Assessment and Report of Drug Dosing frequency by number of protrusions of tactile label
Secondary Outcome Measures
Full Information
NCT ID
NCT04483882
First Posted
July 20, 2020
Last Updated
December 22, 2021
Sponsor
The University of Texas Medical Branch, Galveston
1. Study Identification
Unique Protocol Identification Number
NCT04483882
Brief Title
Tactile Low Vision Labeling of Ophthalmic Drops
Official Title
Utility and Efficacy of Tactile Labeling of Ophthalmic Drops for Identity and Frequency of Administration in Low Vision
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 24, 2020 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is an evaluation of a tactile labeling strategy developed in the Ophthalmology Clinical Research Center at University of Texas Medical Branch (UTMB) in collaboration with the UTMB Maker Space to improve low vision patients capability to identify their topical ophthalmic drop treatments and the frequency with which they should be administered. The labeling strategy includes protrusions as frequency markers and shapes to differentiate between treatments of similar frequency prescription.
Detailed Description
The purpose of this study is an evaluation of a tactile labeling strategy developed in the Ophthalmology Clinical Research Center at University of Texas Medical Branch (UTMB) in collaboration with the UTMB Maker Space to improve low vision patients capability to identify their topical ophthalmic drop treatments and the frequency with which they should be administered. The labeling strategy includes protrusions as frequency markers and shapes to differentiate between treatments of similar frequency prescription.
The first aim is to evaluate the patient capability to identify the number of protrusions and therefore the frequency of administration prescribed. This should be completed in a timeframe that is not frustrating or problematic to the patient in practice.
The second aim is to evaluate the patient ability to differentiate between drugs with similar frequencies based on a shape on the frequency protrusions in a tactile manner. This also should be completed in a timeframe that is not over burdensome or frustrating to the patient. The protocol is designed to evaluate this tactile labeling design in the population it is designed to support.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Vision Aids
Keywords
Low Vision, Labeling, Tactile
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group, Blinded, Sham controlled study
Masking
Participant
Masking Description
Subjects will be blinded to product to be provided for visual and tactile definition of label product and type and frequency of prescription.
Allocation
Non-Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phase I- Visually Obscured Healthy Subjects
Arm Type
Sham Comparator
Arm Description
Tactile label to be evaluated by healthy subjects without visual defect. Subjects in visually obscuring lenses but without peripheral neuropathies or other tactile deficits will evaluate the tactile labeling product for efficacy in drug identity and dosing definition. .
Arm Title
Phase II- Low Vision Over 50 years of age
Arm Type
Active Comparator
Arm Description
Subjects with documented Low Vision of 20/70 or less or visual field less than 20 degrees will be asked to evaluate tactile labeling product for efficacy in drug identity and dosing definition.
Intervention Type
Device
Intervention Name(s)
Tactile Labels for Drug identity and dose frequency
Intervention Description
The tactile labeling proposed in this protocol is rigid labeling. A ring-clip has an inner diameter of 12.5cm, an outer diameter of 16 cm, and a height of 1.5 cm. The ring is cut at 2 cm to form a semi-circle allowing it to be clipped onto the bottleneck. The ring clip fits most if not all prescription eye drop bottles. The individual protrusions with shapes at the end can be cut off by the pharmacist to match the frequency of administration prescribed.
Primary Outcome Measure Information:
Title
Correct Drug Identity by Shape
Description
Subjects Assessment and Report of drug identity by shape of label protrusions
Time Frame
2 minutes
Title
Correct Drug Identity by Color
Description
Subject Assessment and Report of drug identity by color of tactile label
Time Frame
2 minutes
Title
Correct Dose Frequency by Tactile Protrusions
Description
Subject Assessment and Report of Drug Dosing frequency by number of protrusions of tactile label
Time Frame
2 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
IInclusion Criteria:
Phase I:
Candidates will be healthy adults between 18 and 100 years of age
Candidates will complete the consent briefing and consent documents prior to participating in any study activities.
Phase II:Inclusion Criteria:
Candidates will be between 50 and 100 years of age.
Candidates will have a BCVA equal to or less than 20/70 or have central vision field less than 20 degrees.
Candidates will complete the consent briefing and consent documents prior to participating in any study activities.
Exclusion Criteria:
Phase I:
Candidates who do not complete the consent briefing and indicate consent through completion of consent documents with or without a witness (as indicated by their ability to read the documents for themselves out loud with whatever optical assistance necessary (large print, magnification, optical correction, etc.), prior to any study activity, will not be included in this study.
History of prior non-compliance or the presence or history of psychiatric condition (including drug or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigators instructions.
Phase II;
Candidates under 50 years or older than 100 years of age will be excluded.
Candidates with a BCVA better than 20/70 or have central vision field greater than 20 degrees, will be excluded.
Candidates with comorbidities that in the opinion of the investigator confound their ability to complete the assessments in this study (ie. Advanced neuropathy of the hands, dementia, or mental incapacity) will be excluded.
Candidates who do not complete the consent briefing and indicate consent through completion of consent documents with or without a witness (as indicated by their ability to read the documents for themselves out loud with whatever optical assistance necessary (large print, magnification, optical correction, etc.), prior to any study activity, will not be included in this study.
History of prior non-compliance or the presence or history of psychiatric condition (including drug or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigators instructions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Praveena Gupta, O.D., Ph.D.
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Medical Branch, Ophthalmology Clinical Research Center
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual's data will not be shared in an identifiable format.
Learn more about this trial
Tactile Low Vision Labeling of Ophthalmic Drops
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