Evaluation of Onefit Scleral Lenses in the Mangement of Dry Eye

Study Overview
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Brief Summary
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This study is being conducted to determine if scleral lenses coated with Hydra-PED improve comfort and dryness.

Detailed Description
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The objective of the study is to determine if scleral lenses with and scleral lenses without Hydra-PEG coating provide positive improvement in ocular comfort and dryness scores. The effect of the study lenses and the coating, will be compared in a group of symptomatic soft lens wearers, and also in a group of symptomatic non contact lens wearers. The primary outcome variable for this study is overall ocular comfort reported at the screening visit for the habitual vision correction, and at the 4-week follow-up visits for each of the two study lenses. using a 0-10 scale (0.5 steps).

Official Title
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Evaluation of Onefit Scleral Lenses in the Mangement of Dry Eye

Conditions
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Dry Eye

Intervention / Treatment
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* Device: scleral lens


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Habitual Soft Lens Wearers<br>Each group will be a prospective, randomized, double masked, cross-over, 1-month per arm, daily wear study. Each participant will be active in the study for at least 2 months. | Device: scleral lens<br>* scleral lens with and without hydra-peg coating<br>|
| Experimental: Non Contact Lens Wearers<br>Each group will be a prospective, randomized, double masked, cross-over, 1-month per arm, daily wear study. Each participant will be active in the study for at least 2 months. | Device: scleral lens<br>* scleral lens with and without hydra-peg coating<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall ocular comfort | reported at the screening visit for the habitual vision correction, and at the 4-week follow-up visits for each of the two study lenses. using a 0-10 scale (0.5 steps) | 4 weeks |