Neurosensory Abnormalities in SymptomAtic Ocular Surface Patients (NASA)

Dry Eye Clinical Trial

— NASA  

Official title:

Neurosensory Abnormalities in SymptomAtic Ocular Surface Patients (NASA)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04838223
• Other study ID #: 00000319
• Status: Enrolling by invitation
• Start date: July 2, 2021
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is designed to measure how common nerve abnormalities are within a group of patients who feel discomfort within their eyes.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: July 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Presents with ocular surface discomfort or for dry eye care

• Best corrected visual acuity of 20/40 or better in each eye

• Subject reported duration of symptoms of at least 3 months

• 100 subjects will be required to be habitual contact lens wearers as defined by use of contact lenses at least 5 hours per day at least 5 days per week for the last year.

Exclusion Criteria:

• Use of contact lenses on the day of the visit

• Pregnant or nursing

• Irregular corneas (e.g., ectatic disease, transplantation, or corneal dystrophies)

• Ocular surgery in the past 3 months

• Ocular infection in the past 3 months

• Active ocular allergies

Related Conditions & MeSH terms

• Dry Eye
• Neuralgia
• Neuropathic Pain

Intervention

Other:
• Hyperosmolar Response
A single drop of hypertonic sodium chloride solution at room temperature will be instilled in each eye and change in pain/other symptoms after up to 90 seconds of application (to account for any initial irritation symptoms) will be observed.
• Proparacaine Challenge Test
A single drop of Proparacaine hydrochloride ophthalmic solution, (Alcaine®, 0.5%) will be used on each eye respectively and any change in pain/other symptoms will be noted after 90 seconds (to account for initial discomfort from the preservative in Proparacaine solution).
• Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Optional; only for Contact Lens Wearers
The CLDEQ-8 is a validated eight-item scaled questionnaire developed to reflect the overall opinion of soft contact lenses.
• Ocular Pain Assessment Survey (OPAS)
Twenty seven-item quantitative questionnaire designed to provide an assessment of the symptoms and quality of life effect of ocular pain [18]. The 27 items of the OPAS questionnaire are graded on a scale of 0 to 10, or 10 to 100, where 0 indicates none and 10 or 100 indicate maximum.
• Visual Analogue Questionnaire
Symptoms of ocular comfort and dryness will be graded for each eye on a scale of 0-10, where 0=extremely uncomfortable, extremely dry and 10=excellent comfort, no dryness. An average rating will be provided for the morning, afternoon and evening.

Locations

Country	Name	City	State
United States	Canyon City Eye Care	Azusa	California
United States	University of Maryland	Baltimore	Maryland
United States	Korb & Associates	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Illinois College of Optometry	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Baylor College of Medicine	Houston	Texas
United States	Bruce W. Carter VA Medical Center	Miami	Florida
United States	Hospital of the University of Pennsylvania (Scheie Eye Institute Perelman)	Philadelphia	Pennsylvania
United States	Kannarr Eye Care	Pittsburg	Kansas
United States	Western University of Health Sciences	Pomona	California
United States	Midwest Vision Research Foundation at Prepose Vision Institute	Saint Louis	Missouri
United States	Ophthalmology Associates	Saint Louis	Missouri
United States	University of California at San Francisco - Francis I Proctor Foundation	San Francisco	California
United States	Vita Eye Clinic	Shelby	North Carolina
United States	SkyVision Centers	Westlake	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Tufts Medical Center	Bausch & Lomb Incorporated, Coopervision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish the prevalence of neuropathic corneal pain in patients with ocular surface discomfort.	As measured by the percent of subjects who report increased ocular surface discomfort upon challenge with hyperosmolar saline.	Day 1
Primary	To assess the overlap of neuropathic corneal pain with dry eye disease in patients in diseases that are currently thought to be mutually exclusive.	As measured by the percent of subjects who report ocular surface discomfort, and either do or do not exhibit signs of dry eye disease as defined by Tear Break Up Time, Schirmer's test, and staining, and have an increase in Visual Analog Scale score of more than 2 steps upon instillation of hypertonic saline.	Day 1
Primary	To establish the prevalence of subtypes of patients with neuropathic corneal pain or with a neuropathic component of dry eye in patients with ocular surface discomfort.	As measured by the percent of subjects who report ocular surface discomfort, and have a decrease, partial decrease, or no change in Visual Analog Score score upon instillation of proparacaine.	Day 1
Secondary	To assess the overlap of neuropathic corneal pain and contact lens discomfort.	Percent of contact lens wearers who report discomfort when wearing their contact lenses, and either do or do not exhibit signs of dry eye disease as defined by TBUT, Schirmer's test, and staining, and have an increase in VAS score of more than 2 steps upon instillation of hypertonic saline.	1 study visit
Secondary	To establish the prevalence of anxiety/depression in patients with neuropathic corneal pain patients.	Percent of subjects who report increased ocular surface discomfort upon challenge with hyperosmolar saline and a history of anxiety/depression.	Day 1
Secondary	To assess for differences in in vivo confocal microscopy measures between dry eye disease patients and neuropathic corneal pain patients.	As measured by dendritic cell density, nerve fiber density, and microneuroma density	Day 1
Secondary	To assess for subtypes of neuropathic corneal pain differences in in vivo confocal microscopy measures between dry eye disease patients and neuropathic corneal pain patients.	As measured by dendritic cell density, nerve fiber density, and microneuroma density	Day 1