Neurosensory Abnormalities in SymptomAtic Ocular Surface Patients (NASA)

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

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

Conditions
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Dry Eye, Neuropathic Pain

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neuropathic Corneal Pain with Ocular Surface Discomfort<br>Participants diagnosed with neuropathic corneal pain with ocular surface discomfort | Other: Hyperosmolar Response<br>* 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.<br>Other: Proparacaine Challenge Test<br>* 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).<br>Other: Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Optional; only for Contact Lens Wearers<br>* The CLDEQ-8 is a validated eight-item scaled questionnaire developed to reflect the overall opinion of soft contact lenses.<br>Other: Ocular Pain Assessment Survey (OPAS)<br>* 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.<br>Other: Visual Analogue Questionnaire<br>* 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.<br>|
| Neuropathic Corneal Pain with Dry Eye Disease<br>Participants diagnosed with dry eye disease and neuropathic corneal pain | Other: Hyperosmolar Response<br>* 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.<br>Other: Proparacaine Challenge Test<br>* 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).<br>Other: Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Optional; only for Contact Lens Wearers<br>* The CLDEQ-8 is a validated eight-item scaled questionnaire developed to reflect the overall opinion of soft contact lenses.<br>Other: Ocular Pain Assessment Survey (OPAS)<br>* 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.<br>Other: Visual Analogue Questionnaire<br>* 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.<br>|
| NCP or Dry Eye in patients with ocular surface discomfort<br>Participants diagnosed with neuropathic corneal pain or with a neuropathic component of dry eye in patients with ocular surface discomfort | Other: Hyperosmolar Response<br>* 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.<br>Other: Proparacaine Challenge Test<br>* 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).<br>Other: Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Optional; only for Contact Lens Wearers<br>* The CLDEQ-8 is a validated eight-item scaled questionnaire developed to reflect the overall opinion of soft contact lenses.<br>Other: Ocular Pain Assessment Survey (OPAS)<br>* 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.<br>Other: Visual Analogue Questionnaire<br>* 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.<br>|

What is the study measuring?
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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 |