A Research Study To See How Well an Eye Drop, SURF-100 (A Mycophenolic Acid/Betamethasone Sodium Phosphate Combination), Works and What Side Effects There Are in Subjects With Dry Eye Disease

Exclusion Criteria

• •1. Contraindications or known hypersensitivity to the study drug(s), including RESTASIS or XIIDRA, or their components.
• •2. Subjects who are employees or immediate family members of employees at the investigational site.
• •3. Subjects who are members of the same household.
• •4. Any ocular condition that, in the opinion of the investigator, may affect study parameters including, but not limited to, lid margin disorders (e.g., blepharitis including staphylococcal, demodex, or seborrheic; excessive lid laxity, floppy eyelid syndrome, ectropion, entropion), advanced conjunctivochalasis, Salzmann's nodular degeneration, and asthenopia-related conditions, allergic conjunctivitis, glaucoma, diabetic retinopathy, follicular conjunctivitis, iritis, uveitis, wet-exudative age-related macular degeneration, retinal vein occlusion, and/or active ocular inflammation.
• •5. Any condition that could affect trigeminal nerve function including facial or ocular Herpes Zoster/Shingle, a stroke or nerve palsy affecting the eye(s).
• •6. Use of any topical medication and/or antibiotics for the treatment of blepharitis or meibomian gland disease in either eye within 14 days prior to Visit 2 (Day 0).
• •7. Active or history of ocular herpes or any other ocular infection in either eye within the last 30 days prior to Visit 1 (Day -14 to Day 0).
• •8. Unwilling to avoid wearing contact lenses for 7 days prior to Randomization (Visit 2, Day 0) and for the duration of the study period (through Visit 7, Day 98).
• •9. Positive urine pregnancy test at Screening, nursing an infant or planning to become pregnant during the study.
• •10. Any blood donation or significant loss of blood within 56 days of Visit 1 (Day -14 to Day 0).
• •11. Any history of immunodeficiency disorder, human immunodeficiency virus (HIV), positive hepatitis B, C, or evidence of acute active hepatitis A (anti-hepatitis A virus immunoglobulin M), or organ or bone marrow transplant.
• •12. Any medication (oral or topical) known to cause ocular drying that is not administered as a stable dose for at least 30 days prior to Visit 1 (Day -14 to Day 0) and for the duration of the study (Visit 7, Day 98); antihistamines are not allowed at any time during the study.
• •13. Use of prohibited medications (topical, topical ophthalmic and/or systemic, during the appropriate pre-study washout period (see below) and during the study. Prohibited medications include topical cyclosporine or lifitegrast, use of any other ophthalmic medication (e.g., glaucoma medication, topical anti-inflammatory eye drops) for the duration of the study)
• •NOTE: Supplements containing omega-3 are allowed if the subject has been taking said supplement for at least 3 months prior to Screening. Subjects are not allowed to begin taking supplements containing omega-3 during the study. The appropriate pre-study washout period is as follows:
• •1. Antihistamines (including ocular): 7 days prior to Visit 1 (Day -14 to Day 0).
• •2. Topical cyclosporine or lifitegrast or omega-3s within 14 days prior to Visit 1 (Day -14 to Day 0).
• •3. Corticosteroids or mast cell stabilizers (including ocular): 14 days prior to Visit 1 (Day -14 to Day 0).
• •4. Depot-corticosteroids in either eye at least 45 days prior to the first dose of study drug (Day 0)
• •5. All other topical ophthalmic preparations (including artificial tear substitutes other than the study drops): 72 hours prior to Visit 1 (Day -14 to Day 0).
• •6. Introduction of any new, nonsteroidal anti-inflammatory drugs (NSAIDs) including but not limited to topical, systemic (including sleep-aids containing NSAIDs), inhaled, or irrigation solution within 7 days prior to the first dose of study drug. Subjects who are on stable dose of NSAIDs (stable for at least 4 weeks prior to the first dose of study drug) are eligible for participation and should remain on a stable dose throughout the duration of the study (i.e., through Day 98).
• •7. Triamcinolone in either eye at least 90 days prior to the first dose of study drug (Day 0).
• •8. Inhaled, ingested, sublingual, transdermal or topical products containing marijuana, tetrahydrocannabinol (THC) or cannabidiol (CBD) at least 7 days prior to the first dose of study drug (Day 0).
• •9. Systemic pain relievers, analgesics (e.g., pregabalin, gabapentin, opioids) 14 days prior to the first dose of study drug (Day 0).
• •10. Any supplement, prescribed medication or over-the-counter product that the investigator feels may interfere with the study parameters, including homeopathic remedies, analgesics, and pain medication.
• •11. Oral doxycycline within 6 months of first dose of study drug (Day 0).
• •12. Diuretics: Within 28 days prior to Visit 1 (Day -14 to Day -1).
• •13. Punctal occlusion:
• •i. Punctal cauterization: Randomization may not occur until 4 weeks following the procedure.
• •ii. Permanent/semi-permanent punctal plugs (this includes 180-day punctal plugs): Randomization may not occur until 4 weeks following the procedure. If a punctal plug falls out during the study, it should be reinserted.
• •iii. Temporary collagen punctal plugs: Not permitted. If subject has a history of use of temporary punctal plugs, randomization may not occur until 4 weeks since last insertion and puncta are plug-free, as determined by the investigator.
• •14. Any significant chronic illness that, in the opinion of the investigator, could interfere with the study parameters, including, but not limited to, severe cardiopulmonary disease, poorly controlled hypertension, and/or poorly controlled diabetes.
• •15. Use of any investigational product or device within 30 days prior to Visit 1 (Day -14 to Day 0) or during the study period.
• •16. History of LASIK or similar type of corneal refractive surgery within 12 months prior to Visit 1 (Day -14 to Day 0), and/or any other ocular surgical procedure within 12 months prior to Visit 1 (Day -14 to Day 0); or any scheduled ocular surgical procedure during the study period.
• •17. Use of any laser procedure for the eyes in the 30 days prior to Visit 1 (Day -14 to Day 0).
• •18. Known history of alcohol and/or drug abuse within the past 12 months that in the opinion of the principal investigator, may interfere with study compliance, outcome measures including safety parameters, and/or the general medical condition of the subject.
• •20. Subjects who test positive for the COVID-19 virus within 30 days prior to Visit 1 (Day -14 to Day 0).