Neurosensory Abnormalities in SymptomAtic Ocular Surface Patients (NASA) (NASA)

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Dry Eye; Neuropathic Pain
• Intervention / Treatment: Other: Hyperosmolar Response; Other: Proparacaine Challenge Test; Other: Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Optional; only for Contact Lens Wearers; Other: Ocular Pain Assessment Survey (OPAS); Other: Visual Analogue Questionnaire

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• United States
  • California
    • Azusa, California, United States, 91702
      • Canyon City Eye Care
    • Pomona, California, United States, 91766
      • Western University of Health Sciences
    • San Francisco, California, United States, 94143
      • University of California at San Francisco - Francis I Proctor Foundation
  • Colorado
    • Denver, Colorado, United States, 80045
      • University of Colorado Hospital
  • Florida
    • Fort Lauderdale, Florida, United States, 33314
      • Nova Southeastern University College of Optometry
    • Miami, Florida, United States, 33125
      • Bruce W. Carter VA Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago
    • Chicago, Illinois, United States, 60616
      • Illinois College of Optometry
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Kannarr Eye Care
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Boston, Massachusetts, United States, 02215
      • Korb & Associates
  • Missouri
    • Saint Louis, Missouri, United States, 63131
      • Ophthalmology Associates
    • Saint Louis, Missouri, United States, 63128
      • Midwest Vision Research Foundation at Prepose Vision Institute
  • New York
    • Buffalo, New York, United States, 14209
      • Ross Eye Institute
  • North Carolina
    • Shelby, North Carolina, United States, 28150
      • Vita Eye Clinic
  • Ohio
    • Westlake, Ohio, United States, 44145
      • SkyVision Centers
  • Oklahoma
    • Edmond, Oklahoma, United States, 73003
      • BeSpoke Vision
  • Pennsylvania
    • New Holland, Pennsylvania, United States, 17557
      • Andrews Eye Corporation DBA Optometric Associates
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania (Scheie Eye Institute Perelman)
    • Shrewsbury, Pennsylvania, United States, 17349
      • Medical Optometry America
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • University of Tennessee Health Science Center (Hamilton Eye Institute)
  • Texas
    • Austin, Texas, United States, 78756
      • Eye Physicians of Austin
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

1,000 subjects will be enrolled for this study based on the above criteria:

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neuropathic Corneal Pain with Ocular Surface Discomfort; Participants diagnosed with neuropathic corneal pain with ocular surface discomfort	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.; Other: 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).; Other: 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.; Other: 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.; Other: 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.
Neuropathic Corneal Pain with Dry Eye Disease; Participants diagnosed with dry eye disease and neuropathic corneal pain	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.; Other: 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).; Other: 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.; Other: 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.; Other: 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.
NCP or Dry Eye in patients with ocular surface discomfort; Participants diagnosed with neuropathic corneal pain or with a neuropathic component of dry eye in patients with ocular surface discomfort	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.; Other: 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).; Other: 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.; Other: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Tufts Medical Center
• Collaborators: Bausch & Lomb Incorporated; Coopervision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2021
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Proxymetacaine
• Other Study ID Numbers: 00000319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No