Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution

• Adult male and female subjects of any race or ethnicity who are ≥18 years of age.
• Best corrected CL visual acuity of 0.3 Logarithm of the Minimum Angle of Resolution (logMAR) or better in both eyes (Snellen equivalent 20/40).
• Daily, soft, frequent replacement CL wearer (daily disposable, bi-weekly, or monthly CLs).
• Contact Lens Dry Eye Questionnaire (CLDEQ)-8 scores (CLDEQ-8 scores ≥ 12).
• A VAS score of ≥40 for Eye Dryness and End of Day Contact Lens Discomfort.
• A corneal fluorescein staining score on the original NEI scale of ≥3.
• Habitually wears soft CLs for a minimum of 5 days per week for 6 hours per day during the month prior to enrollment.
• Willing to maintain habitual CL wear routine for the 3 months duration of the study.20
• Willing to only use VEVYE for dry eye treatment for the 3 months duration of the study.
• Willing to use VEVYE twice a day even if CL is not worn for that day.
• Habitual CLs have an acceptable fit (good centration, movement, and coverage).20
• Willing to not use any lipid containing artificial tear (AT) for the 3 months duration of the study.
• Willing to only use non-lipid containing preservative free artificial tear for the 3 months duration of the study if needed, but no more than 4 times per day; also must agree to record frequency of daily AT use if applicable.
• Willing to record daily time for CL application, removal, and VEVYE applications.

Exclusion Criteria:

• Any history of VEVYE use within 6 months of enrollment.
• Are currently an overnight CL wearer.
• Are currently wearing rigid gas permeable CLs, scleral CL, hybrid CLs, or custom soft CLs.
• Have known systemic health conditions that are known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome).
• Have a history of ocular surgery within the past 12 months.
• Have a history of viral eye disease.
• Have a history of severe ocular trauma, active ocular infection or inflammation.
• Have ever used or are currently using isotretinoin-derivates (e.g., Accutane).
• Are currently taking ocular medications or plan to during the study (e.g., DED, glaucoma, etc.).
• Are currently taking systemic medications that have anticholinergic properties (e.g., antihistamines, antianxiety, antidepressants, etc.) and use is anticipated to change during the course of the study (anticipated stable use of these drugs is allowed).
• Subjects with meibomian gland blockage or significant atrophy (e.g., severe MGD). Currently having >50% blockage of Meibomian glands in more than two eyelids.
• Having blepharitis and/or demodex blepharitis > grade 2.
• Have had a physical meibomian gland dysfunction treatment within 3 month of enrollment (iLux, Lipiflow, Radio Frequency and IPL with manual expressions, microblepharoexfoliation etc.).
• Have used a prescription DED or ocular surface disease medication in the last 1 month.
• Have used Lacrifill withing 1 month of enrollment.
• Have a condition or in a situation, which in the examiner's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation.
• Are pregnant or breast feeding or plan to get pregnant. Note: To participate in this study, subjects of child bearing potential must be on an adequate form of birth control, which can include but not limited to: Barrier methods; Hormonal contraceptives; Surgical sterilization (tubal ligation > 5 years ago, hysterectomy); Intrauterine device; Vasectomized male partner must be sole partner and procedure performed >1 year prior to study participation; Abstinence.