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Neurosensory Abnormalities in SymptomAtic Ocular Surface Patients (NASA)

Tufts University logo

Tufts University

Status

Invitation-only

Conditions

Dry Eye
Neuropathic Pain

Treatments

Other: Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Optional; only for Contact Lens Wearers
Other: Visual Analogue Questionnaire
Other: Hyperosmolar Response
Other: Ocular Pain Assessment Survey (OPAS)
Other: Proparacaine Challenge Test

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT04838223
00000319

Details and patient eligibility

About

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

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

1,000 participants in 3 patient groups

Neuropathic Corneal Pain with Ocular Surface Discomfort
Description:
Participants diagnosed with neuropathic corneal pain with ocular surface discomfort
Treatment:
Other: Proparacaine Challenge Test
Other: Ocular Pain Assessment Survey (OPAS)
Other: Hyperosmolar Response
Other: Visual Analogue Questionnaire
Other: Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Optional; only for Contact Lens Wearers
Neuropathic Corneal Pain with Dry Eye Disease
Description:
Participants diagnosed with dry eye disease and neuropathic corneal pain
Treatment:
Other: Proparacaine Challenge Test
Other: Ocular Pain Assessment Survey (OPAS)
Other: Hyperosmolar Response
Other: Visual Analogue Questionnaire
Other: Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Optional; only for Contact Lens Wearers
NCP or Dry Eye in patients with ocular surface discomfort
Description:
Participants diagnosed with neuropathic corneal pain or with a neuropathic component of dry eye in patients with ocular surface discomfort
Treatment:
Other: Proparacaine Challenge Test
Other: Ocular Pain Assessment Survey (OPAS)
Other: Hyperosmolar Response
Other: Visual Analogue Questionnaire
Other: Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Optional; only for Contact Lens Wearers

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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