Neurosensory Abnormalities in SymptomAtic Ocular Surface Patients (NASA)

• Conditions: Neuropathic Pain; Dry Eye

• Registration Number: NCT04838223
• Lead Sponsor: Tufts Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-09
• Study Start: 2021-07-02
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-10
• Primary Completion: 2025-05-31
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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.
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.

Secondary Outcome Measures

Name	Time	Method
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 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 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

Trial Locations

Locations (16)

Canyon City Eye Care; 🇺🇸 Azusa, California, United States

Western University of Health Sciences; 🇺🇸 Pomona, California, United States

University of California at San Francisco - Francis I Proctor Foundation; 🇺🇸 San Francisco, California, United States

Bruce W. Carter VA Medical Center; 🇺🇸 Miami, Florida, United States

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States

Illinois College of Optometry; 🇺🇸 Chicago, Illinois, United States

Kannarr Eye Care; 🇺🇸 Pittsburg, Kansas, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Korb & Associates; 🇺🇸 Boston, Massachusetts, United States

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