NCT04838223|Suspended
Study Stopped
PI is leaving insitution. This study is no longer active at TMC.
Neurosensory Abnormalities in SymptomAtic Ocular Surface Patients (NASA)
NASA
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PI is leaving insitution. This study is no longer active at TMC.
NASA
Sponsor study identifier
observational
1,000
1 country
16
Study Start
July 2, 2021
Actual (reported)Primary Completion
December 31, 2025
Actual (reported)Study Completion
July 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study is designed to measure how common nerve abnormalities are within a group of patients who feel discomfort within their eyes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 19, 2020
Actual (reported)April 9, 2021
Actual (reported)July 2, 2021
Actual (reported)December 31, 2025
Actual (reported)July 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
To assess the overlap of neuropathic corneal pain and contact lens discomfort.
1 study visit
To establish the prevalence of anxiety/depression in patients with neuropathic corneal pain patients.
Day 1
To assess for differences in in vivo confocal microscopy measures between dry eye disease patients and neuropathic corneal pain patients.
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.
Day 1
Participants diagnosed with neuropathic corneal pain with ocular surface discomfort
Participants diagnosed with dry eye disease and neuropathic corneal pain
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.
1,000 subjects will be enrolled for this study based on the above criteria:
Canyon City Eye Care
Azusa, California, 91702, United States
Western University of Health Sciences
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
Pedram Hamrah, MD
Tufts Medical Center
First Submitted
August 19, 2020
First Posted
April 9, 2021
Study Start
July 2, 2021
Actual (reported)Primary Completion
December 31, 2025
Actual (reported)Ocular Inflammation in Cataract Patients and Response to Treatment With Xiidra
Participants diagnosed with neuropathic corneal pain or with a neuropathic component of dry eye in patients with ocular surface discomfort
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).
The CLDEQ-8 is a validated eight-item scaled questionnaire developed to reflect the overall opinion of soft contact lenses.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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
Study Completion
July 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 27, 2026
Record last verified: 2026-01
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Source: ClinicalTrials.gov.
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