Neurosensory Abnormalities in SymptomAtic Ocular Surface Patients (NASA)

Sponsor

Tufts Medical Center (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04838223

Collaborator

Coopervision, Inc. (Industry), Bausch & Lomb Incorporated (Industry)

1,000

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Neuropathic Pain	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 Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Neurosensory Abnormalities in SymptomAtic Ocular Surface Patients (NASA)

Actual Study Start Date :

Jul 2, 2021

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	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.

Arm

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

Other: Proparacaine Challenge Test

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)

Other: Visual Analogue Questionnaire

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

Other: Proparacaine Challenge Test

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)

Other: Visual Analogue Questionnaire

Outcome Measures

Primary Outcome Measures

To establish the prevalence of neuropathic corneal pain in patients with ocular surface discomfort. [Day 1]
As measured by the percent of subjects who report increased ocular surface discomfort upon challenge with hyperosmolar saline.
To assess the overlap of neuropathic corneal pain with dry eye disease in patients in diseases that are currently thought to be mutually exclusive. [Day 1]
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.
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. [Day 1]
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.

Secondary Outcome Measures

To assess the overlap of neuropathic corneal pain and contact lens discomfort. [1 study visit]
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.
To establish the prevalence of anxiety/depression in patients with neuropathic corneal pain patients. [Day 1]
Percent of subjects who report increased ocular surface discomfort upon challenge with hyperosmolar saline and a history of anxiety/depression.
To assess for differences in in vivo confocal microscopy measures between dry eye disease patients and neuropathic corneal pain patients. [Day 1]
As measured by dendritic cell density, nerve fiber density, and microneuroma density
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. [Day 1]
As measured by dendritic cell density, nerve fiber density, and microneuroma density

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

Tufts Medical Center
Coopervision, Inc.
Bausch & Lomb Incorporated

Investigators

Principal Investigator: Pedram Hamrah, MD, Tufts Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tufts Medical Center

ClinicalTrials.gov Identifier:

NCT04838223

Other Study ID Numbers:

00000319

First Posted:

Apr 9, 2021

Last Update Posted:

Jun 13, 2022

Last Verified:

Jun 1, 2022

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:

Additional relevant MeSH terms:

Neuralgia

Proxymetacaine

Study Results

No Results Posted as of Jun 13, 2022