Evaluation of Onefit Scleral Lenses in the Mangement of Dry Eye

Inclusion Criteria: Are at least 17 years of age and have full legal capacity to volunteer; Have read and signed an information consent letter; Are willing and able to follow instructions and maintain the appointment schedule; Agree to wear the study scleral lenses for at least 8 hours per day, 5 days a week; Have a refraction between +20.00 and -20.00D and spectacle astigmatism of no more than -3.00DC in each eye; Have best corrected visual acuity of 20/40 or better in each eye with the study lenses; Demonstrate an acceptable fit with the study lenses; Have no active ocular disease or inflammation; Group 1: Habitual wearer of frequent replacement or daily disposable soft lenses; Group 2: Have not worn contact lenses for 6 months; Group 1: Contact lens wearers should score ≥12 on CLDEQ-8; Group 2: Non contact lens wearers should score ≥13 on OSDI. Exclusion Criteria: Are participating in any concurrent clinical or research study, or have done so within the past 30 days; Cannot achieve a successful lens fit or vision with the study lens; Have been diagnosed with keratoconus or corneal distortion; Have any known active* ocular condition, disease and/or infection; Have a systemic or ocular condition that in the opinion of the investigator may affect a study outcome variable e.g. pingueculae; Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; Group 2: Non-contact lens wearers who score ≥33 on OSDI and also demonstrate either corneal staining ≥3 (Oxford scale) or non-invasive tear break-up time ≤3 seconds#; Have known sensitivity to the diagnostic sodium fluorescein to be used in the study; Are pregnant, lactating or planning a pregnancy^ at the time of enrolment, by self report; Have undergone refractive error surgery; Are listed on the Delegation Log for this study.