Research Study To See How Well An Eye Drop (SURF-200) Works, What Side Effects There Are, And To Compare It With Vehicle In Subjects With An Episodic Flare-Up of Dry Eye Disease

Exclusion Criteria

• •1. Females who are pregnant or nursing or planning to become pregnant during the study. Females of childbearing potential (not surgically sterilized or postmenopausal) may not participate in the study if they do not agree to use adequate birth control methods for the duration of the study.
• •2. Use of contact lenses in either eye during the study. Contact lens wear must have been discontinued at least 2 weeks prior to Baseline/Randomization Visit 2 (Day 1).
• •3. Use of corticosteroids or nonsteroidal anti-inflammatory agents (NSAID) (except oral doses of aspirin at 81 mg/day or lower) within 2 weeks of the initiation of study drug at Baseline/Randomization Visit 2 (Day 1) and for the remainder of the study.
• •4. Inhaled, ingested, sublingual, transdermal or topical products containing marijuana, tetrahydrocannabinol (THC) or cannabidiol (CBD) within 7 days of the first dose of study drug at Baseline/Randomization Visit 2 (Day 1) and for the remainder of the study.
• •5. Presence or history of treatment with systemic immunosuppressive or chemotherapeutic agents.
• •6. History of high IOP response to steroids.
• •7. Participated in an ophthalmic investigational product clinical trial within 30 days of Screening Visit 1 (Day -14 to Day 0).
• •8. Active collagen vascular disorder or autoimmune disease.
• •9. 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.
• •10. Known hypersensitivity to any component of the study drug or procedural medications.
• •11. Known hypersensitivity to steroids.
• •12. Any active corneal epithelial/stromal pathology noted in the study eye at Screening Visit 1 (Day -14 to Day 0).
• •13. Any history of corneal surgery in the study eye (including corneal crosslinking, radial keratotomy, corneal transplant, or LASIK).
• •14. Any ocular surgery in the study eye within the past year.
• •15. Subject has punctal occlusion with any modality or a change in punctal plug status in either eye within the 3 months prior to Screening Visit 1 (Day -14 to Day 0).
• •16. Subject has a history of glaucoma.
• •17. Subject has a history of herpes simplex infection in either eye.
• •18. Subject has active corneal, conjunctival or canalicular pathology (including ocular infection \[bacterial, viral or fungal\]) in either eye. Specifically, active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and mycobacterial infection of either eye and fungal diseases of the ocular structures (such as fungal keratitis).
• •19. Subject has thinning of the cornea or sclera in the study eye.
• •20. Subject has active anterior blepharitis in the study eye.
• •21. Subject has a history of uveitis in the study eye.
• •22. Subject is suffering from alcohol and/or drug abuse.
• •23. Subject has tested positive for the COVID-19 virus within 30 days prior to Screening Visit 1 (Day -14 to Day 0).
• •24. Subject has previously received treatment in this study protocol.
• •25. Subject is taking a medication, that in the opinion of the investigator, might interfere with the study parameters.