Tactile Low Vision Labeling of Ophthalmic Drops

Study Overview
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Brief Summary
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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
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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.

Official Title
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Utility and Efficacy of Tactile Labeling of Ophthalmic Drops for Identity and Frequency of Administration in Low Vision

Conditions
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Low Vision Aids

Intervention / Treatment
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* Device: Tactile Labels for Drug identity and dose frequency


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group, Blinded, Sham controlled study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Phase I- Visually Obscured Healthy Subjects<br>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. . | Device: Tactile Labels for Drug identity and dose frequency<br>* 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.<br>|
| Active Comparator: Phase II- Low Vision Over 50 years of age<br>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. | Device: Tactile Labels for Drug identity and dose frequency<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correct Drug Identity by Shape | Subjects Assessment and Report of drug identity by shape of label protrusions | 2 minutes | 
| Correct Drug Identity by Color | Subject Assessment and Report of drug identity by color of tactile label | 2 minutes | 
| Correct Dose Frequency by Tactile Protrusions | Subject Assessment and Report of Drug Dosing frequency by number of protrusions of tactile label | 2 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low Vision, Labeling, Tactile