Neurosensory Abnormalities in SymptomAtic Ocular Surface Patients (NASA)
NCT ID: NCT04838223
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
1000 participants
OBSERVATIONAL
2021-07-02
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Neuropathic Corneal Pain with Ocular Surface Discomfort
Participants diagnosed with neuropathic corneal pain with ocular surface discomfort
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.
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).
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.
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.
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
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.
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).
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.
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.
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
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.
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).
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.
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.
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.
Interventions
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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.
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).
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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CooperVision International Limited (CVIL)
INDUSTRY
Bausch & Lomb Incorporated
INDUSTRY
Tufts Medical Center
OTHER
Responsible Party
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Principal Investigators
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Pedram Hamrah, MD
Role: PRINCIPAL_INVESTIGATOR
Tufts Medical Center
Locations
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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
Midwest Vision Research Foundation at Prepose Vision Institute
St Louis, Missouri, United States
Ophthalmology Associates
St Louis, Missouri, United States
Vita Eye Clinic
Shelby, North Carolina, United States
SkyVision Centers
Westlake, Ohio, United States
Hospital of the University of Pennsylvania (Scheie Eye Institute Perelman)
Philadelphia, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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Other Identifiers
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00000319
Identifier Type: -
Identifier Source: org_study_id
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