Clinical Trials Directory

Trials / Suspended

SuspendedNCT04838223

Neurosensory Abnormalities in SymptomAtic Ocular Surface Patients (NASA)

Status
Suspended
Phase
Study type
Observational
Enrollment
1,000 (estimated)
Sponsor
Tufts Medical Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

Conditions

Interventions

TypeNameDescription
OTHERHyperosmolar ResponseA 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.
OTHERProparacaine Challenge TestA 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).
OTHERContact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Optional; only for Contact Lens WearersThe CLDEQ-8 is a validated eight-item scaled questionnaire developed to reflect the overall opinion of soft contact lenses.
OTHEROcular 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.
OTHERVisual Analogue QuestionnaireSymptoms 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.

Timeline

Start date
2021-07-02
Primary completion
2025-12-31
Completion
2026-07-01
First posted
2021-04-09
Last updated
2026-01-27

Locations

16 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT04838223. Inclusion in this directory is not an endorsement.