Comparison of Conjunctival Goblet Cell Density in Dry Eye Patients Treated With Cyclosporine 0.1% Dissolved in Perfluorobutylpentane (Vevye®) or Generic 0.05% Cyclosporine Emulsion for 8 Weeks

Exclusion Criteria

• •Subjects meeting any of the following criteria at the enrollment visit will be excluded from entry into the study:
• •Ophthalmic:
• •1. History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, interfere with the interpretation of the study results or subject safety, such as: significant conjunctival scarring; pterygium or nodular pinguecula; conjunctivitis, or inflammation not associated with DED; clinically significant anterior blepharitis (Staphylococcal or Demodex).
• •2. Other significant ophthalmic disease requiring topical medication (e.g., glaucoma, ocular hypertension), or other ophthalmic disease which the investigator believes may interfere with study findings or interpretation.
• •3. History of ocular surgery within 1 year prior to the Screening visit, including punctal cautery, corneal refractive, or anterior segment surgeries (e.g., cataract surgery or any surgery creating limbal or corneal incisions).
• •4. History of corneal transplant in one or both eyes.
• •5. Diagnosis of recurrent, ongoing, or active ocular infection including, but not limited to herpes simplex or zoster, bacterial or fungal keratitis.
• •6. Use of contact lenses in either eye within 90 days prior to the enrollment visit or planned use during the study.
• •7. Punctal or intracanalicular plug present in either eyelid within 90 days prior to the enrollment visit or anticipated plug insertion or occlusion at any time during the study.
• •8. Regular use, as assessed by the investigator, of lid hygiene or heat masks within 14 days prior to the Enrollment visit or any planned use during the study.
• •9. Use of lid heating therapy (i.e., LipiFlow®, iLUX®, Thermal OneTouch, TearCare®) or Meibomian gland probing/therapeutic expression within 90 days prior to enrollment or anticipated during the study.
• •10. Use of Intense Pulsed Light (IPL) therapy on eyelids within 90 days prior to enrollment or anticipated during the study.
• •11. Use of artificial tears within 24 hours prior to enrollment or anticipated use during the study.
• •12. Use of any topical ocular cyclosporine A formulation (e.g., ocular cyclosporine \[Restasis®, Cequa™, Vevye™, generics\] within 1 year prior to enrollment. Use of lifitegrast \[Xiidra®\]), perfluorohexyloctane \[Meibo™\]), Tryptyr™, or any topical ocular corticosteroid, or any non-steroidal-anti-inflammatory agents within 90 days prior to enrollment or anticipated use during the study.
• •13. Use of topical ocular autologous serum/plasma within 90 days prior to the enrollment or anticipated use during the study.
• •14. Use of any topical ocular glaucoma medication within 30 days prior to enrollment or anticipated use during the study.
• •15. Regular use, as defined by the investigator, of any other topical ocular medication not listed in Exclusion 11, 12, 13 or 14 within 14 days prior to the enrollment visit or anticipated use during the study (e.g., eye whitening products \[Visine®, Lumify®\], topical ocular antibiotics, topical ocular antihistamines, mast cell stabilizers, presbyopia correcting drops \[e.g., Vuity™\].
• •16. Use of Tyrvaya™ (varenicline solution, nasal spray 0.03 mg) within 90 days prior to the enrollment visit or anticipated use during the study.
• •17. Use of oral medications for the treatment of severe DED and/or Meibomian gland disease such as oral pilocarpine, oral cevimeline, oral macrolides, oral tetracyclines or tetracycline derivatives, and oral retinoids within 30 days prior to enrollment or anticipated use during the study.
• •18. General/Systemic:
• •Initiation, discontinuation, or change in dose of a systemic medication known to cause ocular drying (e.g., antihistamines or antidepressants) less than 30 days prior to enrollment or a change in dosage is anticipated during the study. Note: occasional short-term use of these medications, such as systemic antihistamines will be permitted, provided that use was not within 7 days prior to enrollment. Initiation, discontinuation, or change in dose of a systemic corticosteroid less than 60 days prior to the enrollment visit or a change in dosage is anticipated during the study. Note: Non-ocular topically applied corticosteroids (including topical creams, nasal sprays and inhalers) will be permitted during the study, and the dose is not required to be stable.
• •19. Initiation, discontinuation, or change in dose of a systemic immunomodulator (e.g., hydroxychloroquine, methotrexate, cyclosporine) less than 60 days prior to the enrollment visit or a change in dosage is anticipated during the study.
• •20. Use of an investigational product or device within 30 days prior to the Screening visit.
• •21. At the enrollment visit, at the investigator's discretion, have uncontrolled or severe:
• •1. Systemic allergy
• •2. Rhinitis or sinusitis
• •3. Atopic dermatitis involving the eyelids
• •22. History or presence of significant systemic disease (i.e.: cardiovascular, pulmonary, hepatic, renal, hematologic, immunologic). Significant is defined as any disease that, in the assessment of the Investigator, would put the safety of the subject at risk through participation, or would prevent or confound protocol-specified assessments (e.g., severe rheumatoid arthritis, severe systemic lupus erythematosus, uncontrolled immunodeficiency disease, etc.).
• •23. Known allergies or sensitivity to the study interventions or study diagnostic agents, including sodium fluorescein, lissamine green, etc.
• •24. Pregnant at enrollment, currently breastfeeding or plans to become pregnant or breastfeed during the study.