Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers
This is a prospective, single site, randomized, double masked, comparator-controlled study designed to evaluate the efficacy of lifitegrast ophthalmic solution 5% in treating the symptoms of dry eye in soft contact lens wearers as compared to control. We hypothesize that there will be a significant improvement in dry eye symptoms in contact lens wearers using lifitegrast as compared to those being treated with control (lifitegrast vehicle).
• Subjects must read, understand and sign the Statement of Informed Consent
• Subjects must be at least 18 years of age
• Subjects must be habitual soft contact lens (CL) wearers, with a daily, weekly, bi- weekly or monthly replacement schedule
• Habitual contact lenses must have a suitable fit as determined by the investigator
• Subjects must report a history of dry eye symptoms, for which they have used rewetting drops or Artificial Tears (ATs) in the past 30 days
• Subjects must be willing to discontinue the use of Artificial Tears (ATs) and rewetting drops for the duration of the study
• Subjects must have a score of 12 or higher on the CLDEQ (Contact Lens Dry Eye Questionnaire-8) at baseline
• Subjects must have at least 2 of the following signs of dry eye disease:
∙ High tear osmolarity \> 308 mOsm/L, (milliosmoles per liter) or a difference greater than 8 mOsm/L between eyes
‣ Any corneal staining
‣ Any bulbar conjunctival staining
‣ Low TBUT (tear break up time) (\<10s)
‣ Schirmer \<10mm in either eye
• Subjects must be able to read at least half of the 20/25 (via entrance Snellen visual acuity) or better in each eye in their current contact lens prescription.
⁃ Subjects currently wearing reusable contact lenses must be willing to use Clear Care solution for cleaning and disinfecting throughout the study.