Neurosensory Abnormalities in SymptomAtic Ocular Surface Patients (NASA)

Summary

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

Conditions

• Dry Eye
• Neuropathic Pain

Interventions

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.

Sponsors & Collaborators

• CooperVision International Limited (CVIL)

  collaborator INDUSTRY

• Bausch & Lomb Incorporated

  collaborator INDUSTRY

• Tufts Medical Center

  lead OTHER

Principal Investigators

• Pedram Hamrah, MD · Tufts Medical Center

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-07-02

Primary Completion

2025-12-31

Completion

2026-07-31

Countries

• United States

Study Locations