Effectiveness Study of TRYPTYR in Dry Eye Disease

Patients aged 18 years and older with dry eye disease who present with corneal staining. Planned enrollment is 100 subjects at two sites.

Inclusion Criteria:

• Be able and willing to provide written informed consent and sign a Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed.
• Be able and willing to comply with the study requirements and attend all study visits.
• Be a minimum of 18 years of age of either sex and any race or ethnicity.
• Diagnosis of Dry Eye Disease at least 6 months before enrollment.
• Use of or desired use of artificial tears (AT), autologous serum or specific dry eye medications during the last 6 months prior to the selection phase.
• Symptoms reported on EDS-VAS >= 40 [0-100].
• Total Corneal Fluorescein Staining of >= 7 as assessed by the NEI scale [0-15].
• By subject report, not be pregnant or breastfeeding.

Exclusion Criteria:

• Be a female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy.
• Have known contraindications or sensitivity to the use of any of the study medications or their components.
• Have an active ocular infection at Visit 1 (bacterial, viral, or fungal) in either eye, or evidence of ocular inflammation or symptomatic blepharitis, in the opinion of the investigator.
• In the opinion of the investigator, at Visit 1 have any clinically significant abnormal findings in either eye that would interfere with the interpretation of the study results or subject safety.
• Use of artificial tears 24 hours prior to screening, and any anticipated use throughout the study.
• Use of dry eye prescription medications 30 days prior to screening and throughout the study (includes autologous serum tears, cyclosporine, lifitegrast, varenicline nasal spray, steroids etc)
• Have previously used TRYPTYR (acoltremon 0.003%) ophthalmic solution in the past 6 months prior to screening
• Have less than or equal to +0.6 logarithmic minimum angle of resolution (logMAR) (approximately 20/80 Snellen) distance-corrected visual acuity (DCVA) in each eye at screening.
• Have completed participation in an investigational drug or drug study within 1 month of Visit 1.
• Have a condition or a situation, which, in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.
• Have had ocular surgical intervention (including laser procedures) of any kind within 6 months prior to Visit 1.
• Contact lens wear within 14 days of Visit 1 and unwilling to discontinue contact lens wear for the study duration.
• Use topical ocular medication of any kind (inclusive of LUMIFY®, LATISSE®, glaucoma medications) within 14 days of Visit 1 or throughout the study.
• Be unable to demonstrate proper eyedrop instillation (using a drop of saline from a vial, in office).
• The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.