Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Single Group, Blinded, Sham controlled study
Primary Purpose
Other
Masking
Single (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.

Arm Groups

ArmDescriptionAssigned Intervention
Sham Comparator
Phase I- Visually Obscured Healthy Subjects
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
    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.
Active Comparator
Phase II- Low Vision Over 50 years of age
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
    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.

Recruiting Locations

University of Texas Medical Branch, Ophthalmology Clinical Research Center
Galveston, Texas 77555
Contact:
Mary Schmitz-Brown, B.S. CCRC
409-747-5843
schmitzbrown@icloud.com

More Details

Status
Recruiting
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

Mary Schmitz-Brown, B.S. CCRC
4097475843
meschmit@utmb.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.