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

January 23, 2026 updated by: Tufts Medical Center
This study is designed to measure how common nerve abnormalities are within a group of patients who feel discomfort within their eyes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Azusa, California, United States, 91702
        • Canyon City Eye Care
      • Pomona, California, United States, 91766
        • Western University of Health Sciences
      • San Francisco, California, United States, 94143
        • University of California at San Francisco - Francis I Proctor Foundation
    • Florida
      • Miami, Florida, United States, 33125
        • Bruce W. Carter VA Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
      • Chicago, Illinois, United States, 60616
        • Illinois College of Optometry
    • Kansas
      • Pittsburg, Kansas, United States, 66762
        • Kannarr Eye Care
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, United States, 02215
        • Korb & Associates
    • Missouri
      • St Louis, Missouri, United States, 63131
        • Ophthalmology Associates
      • St Louis, Missouri, United States, 63128
        • Midwest Vision Research Foundation at Prepose Vision Institute
    • North Carolina
      • Shelby, North Carolina, United States, 28150
        • Vita Eye Clinic
    • Ohio
      • Westlake, Ohio, United States, 44145
        • SkyVision Centers
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania (Scheie Eye Institute Perelman)
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

1,000 subjects will be enrolled for this study based on the above criteria:

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Neuropathic Corneal Pain with Ocular Surface Discomfort
Participants diagnosed with neuropathic corneal pain with ocular surface discomfort
Other: Hyperosmolar 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.
Other: Proparacaine 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).
Other: Contact 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.
Other: Ocular 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.
Other: Visual 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.
Neuropathic Corneal Pain with Dry Eye Disease
Participants diagnosed with dry eye disease and neuropathic corneal pain
Other: Hyperosmolar 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.
Other: Proparacaine 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).
Other: Contact 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.
Other: Ocular 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.
Other: Visual 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.
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
Other: Hyperosmolar 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.
Other: Proparacaine 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).
Other: Contact 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.
Other: Ocular 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.
Other: Visual 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To establish the prevalence of neuropathic corneal pain in patients with ocular surface discomfort.
Time Frame: Day 1
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.
Time Frame: 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.
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.
Time Frame: 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.
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To assess the overlap of neuropathic corneal pain and contact lens discomfort.
Time Frame: 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.
1 study visit
To establish the prevalence of anxiety/depression in patients with neuropathic corneal pain patients.
Time Frame: Day 1
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.
Time Frame: Day 1
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.
Time Frame: Day 1
As measured by dendritic cell density, nerve fiber density, and microneuroma density
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tufts Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bausch & Lomb Incorporated
CooperVision International Limited (CVIL)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pedram Hamrah, MD, Tufts Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 2, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 00000319

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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