Tactile Low Vision Labeling of Ophthalmic Drops

NCT04483882 | Completed

• 1 other identifier: 20-0087
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Vision Aids

Keywords

Low Vision, Labeling, Tactile

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Phase I- Visually Obscured Healthy Subjects

SHAM COMPARATOR

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

Phase II- Low Vision Over 50 years of age

ACTIVE COMPARATOR

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

Interventions

Tactile Labels for Drug identity and dose frequency DEVICE

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.

Phase I- Visually Obscured Healthy Subjects; Phase II- Low Vision Over 50 years of age

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch, Ophthalmology Clinical Research Center

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Vision, Low

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Praveena Gupta, O.D., Ph.D.

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will be blinded to product to be provided for visual and tactile definition of label product and type and frequency of prescription.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group, Blinded, Sham controlled study

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 23, 2020
• Study Start: July 24, 2020
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: December 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)