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
| Type | Name | Description |
|---|---|---|
| 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. |
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.