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PI is leaving insitution. This study is no longer active at TMC.
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| Name | Class |
|---|---|
| CooperVision International Limited (CVIL) | INDUSTRY |
| Bausch & Lomb Incorporated | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuropathic Corneal Pain with Ocular Surface Discomfort | Participants diagnosed with neuropathic corneal pain with ocular surface discomfort |
| |
| Neuropathic Corneal Pain with Dry Eye Disease | Participants diagnosed with dry eye disease and neuropathic corneal pain |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperosmolar Response | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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1,000 subjects will be enrolled for this study based on the above criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pedram Hamrah, MD | Tufts Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canyon City Eye Care | Azusa | California | 91702 | United States | ||
| Western University of Health Sciences |
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| Proparacaine Challenge Test | Other | 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 | Other | 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) | Other | 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 | Other | 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. |
|
| 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 |
| Pomona |
| California |
| 91766 |
| United States |
| University of California at San Francisco - Francis I Proctor Foundation | San Francisco | California | 94143 | United States |
| Bruce W. Carter VA Medical Center | Miami | Florida | 33125 | United States |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| Illinois College of Optometry | Chicago | Illinois | 60616 | United States |
| Kannarr Eye Care | Pittsburg | Kansas | 66762 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Korb & Associates | Boston | Massachusetts | 02215 | United States |
| Midwest Vision Research Foundation at Prepose Vision Institute | St Louis | Missouri | 63128 | United States |
| Ophthalmology Associates | St Louis | Missouri | 63131 | United States |
| Vita Eye Clinic | Shelby | North Carolina | 28150 | United States |
| SkyVision Centers | Westlake | Ohio | 44145 | United States |
| Hospital of the University of Pennsylvania (Scheie Eye Institute Perelman) | Philadelphia | Pennsylvania | 19104 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012847 | Single Person |
| ID | Term |
|---|---|
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |
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