Tactile Low Vision Labeling of Ophthalmic Drops

Sponsor

The University of Texas Medical Branch, Galveston (Other)

Overall Status

Completed

CT.gov ID

NCT04483882

Collaborator

(none)

Enrollment

Location

Arms

16.7

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Low Vision Aids	Device: Tactile Labels for Drug identity and dose frequency	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single Group, Blinded, Sham controlled studySingle Group, Blinded, Sham controlled study

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.

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jul 24, 2020

Actual Primary Completion Date :

Dec 15, 2021

Actual Study Completion Date :

Dec 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Correct Drug Identity by Shape [2 minutes]
Subjects Assessment and Report of drug identity by shape of label protrusions
Correct Drug Identity by Color [2 minutes]
Subject Assessment and Report of drug identity by color of tactile label
Correct Dose Frequency by Tactile Protrusions [2 minutes]
Subject Assessment and Report of Drug Dosing frequency by number of protrusions of tactile label

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Medical Branch, Ophthalmology Clinical Research Center	Galveston	Texas	United States	77555

Sponsors and Collaborators

The University of Texas Medical Branch, Galveston

Investigators

Principal Investigator: Praveena Gupta, O.D., Ph.D., University of Texas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The University of Texas Medical Branch, Galveston

ClinicalTrials.gov Identifier:

NCT04483882

Other Study ID Numbers:

20-0087

First Posted:

Jul 23, 2020

Last Update Posted:

Dec 23, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by The University of Texas Medical Branch, Galveston

Low Vision, Labeling, Tactile

Additional relevant MeSH terms:

Vision, Low

Study Results

No Results Posted as of Dec 23, 2021