Prospective Study to Validate the Imaging Biomarker for NCP (R33)

Eligibility Criteria

• 1. 18 years of age or older
• 2. Ability to consent
• 3. Best corrected visual acuity of 20/40 or better in each eye
• 1. Chief complaint is ocular surface discomfort or dry eye disease, but subject reports no ocular pain on OPAS questionnaire
• 2. Symptoms lasting at least 3 months
• 3. Presence of at least two of the following within the same eye:
• 1. Anesthetized Schirmer score =/\< 10mm
• 2. Corneal staining of \>3/15 based on NEI scale
• 3. Tear break up time \< 10 seconds
• 1. Chief complain is ocular surface discomfort or dry eye disease
• 2. Symptoms lasting at least 3 months
• 3. All of the following in both eyes:
• 1. Corneal staining of less than or equal to 3/15 based on NEI scale
• 2. Tear break up time =/\> 10 seconds
• 4. Must have at least 25% peripheral pain
• 5. Subject reported discomfort prior to drop response testing of at least 3 out of 10
• 1. No symptoms of ocular surface discomfort or dry eye disease
• 2. All of the following in both eyes
• 1. Anesthetized Schirmer score \> 10 mm
• 2. Corneal staining of less than or equal to 3/15 based on NEI scale
• 3. Tear break up time \> 10 seconds
• 3. The same sex and within 5 years of age of a patient within the NCP group.
• 1. Pregnant or nursing
• 2. Irregular corneal disease
• 3. Ocular surgery in the past 3 months
• 4. Ocular infection in the past 3 months
• 5. Active ocular allergies
• 6. Participation in a study that could potentially impact the IVCM in the opinion of the investigator
• 7. Current use of corneal nerve regeneration therapy that has been on-going for 3 months or more.
• 8. For NCP group only, patients for whom their pain and symptoms can be attributed to other causes in the opinion of the investigator