Randomized Single Center Study to Evaluate Tolerability, Symptoms, and Visual Functional Outcomes With the Use of OTC Lubricating Eye Drops in Subjects With Dry Eye Disease

Inclusion criteria

• Be at least 18 years of age, male or female
• Able to provide written voluntary informed consent
• Able and willing to adhere to the protocol instructions, including participation in all study visits
• Subject-reported symptoms or history consistent with dry eye for at least 6 months prior to Screening/Baseline (Visit 1)
• Ocular Surface Disease Index (OSDI) score >13

Exclusion criteria

Note: All ocular exclusion criteria apply to either eye.

• DED secondary to destruction of conjunctival goblet cells due to ocular trauma (eg, alkali burns) or ocular or systemic condition (eg, Stevens-Johnson syndrome, ocular cicatricial pemphigoid, Vitamin A deficiency)
• Any abnormal lid or corneal anatomy that would interfere with eyelid closure or create an irregular ocular tear film
• Any active ocular infection, inflammation, or ocular allergy
• Have undergone ocular surgery or laser refractive surgery within 9 months prior to Screening/Baseline (Visit 1)
• Use of LipiFlow® procedure, intense pulse light procedure, or any kind of other procedure affecting meibomian glands within 6 months prior to Screening/Baseline (Visit 1)
• Occlusion of the ocular puncta within 30 days prior to Screening/Baseline (Visit 1)
• Have worn contact lenses within 3 days prior to Screening/Baseline (Visit 1) or planned wear during the study
• Use of topical prescription products for dry eye, including topical ocular anti inflammatories (eg, cyclosporine, lifitegrast), corticosteroids, MIEBO® (perfluorohexyloctane ophthalmic solution), or TRYPTYR® (alcotremon ophthalmic solution) within 30 days prior to Screening/ Baseline (Visit 1)
• Use of any eye drops (prescription or OTC, such as artificial tears or Lumify®) and/or TrueTear™ device (intranasal tear neurostimulator) within 24 hours prior to Screening/ Baseline (Visit 1)
• Changes in any systemic medications known to impact tear production (eg, antihistamines, antidepressants, hormone replacement therapy, etc.) within 3 months prior to Screening/Baseline (Visit 1)
• Have a serious or uncontrolled systemic disease (eg, diabetes, rheumatoid arthritis, lupus, hypertension, malignancy) that, in the opinion of the Investigator, will interfere with the study or interpretation of study results