Dry Eye, Neuropathic Pain
Conditions
Brief summary
This study is designed to measure how common nerve abnormalities are within a group of patients who feel discomfort within their eyes.
Interventions
OTHERHyperosmolar 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.
OTHERProparacaine 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).
OTHERContact 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.
OTHEROcular 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.
OTHERVisual 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.
Sponsors
Tufts Medical Center
CooperVision International Limited (CVIL)
Bausch & Lomb Incorporated
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPedram Hamrah, MD
Tufts Medical Center
Outcome results
None listed