Performance of Fanfilcon A Toric Lenses After at Least One Month Wearing Enfilcon A Toric Lenses

Study Overview
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Brief Summary
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This is a prospective, multi-center, subject-masked, bilateral, daily wear, two-month dispensing study

Detailed Description
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The aim of this study is to determine if adapted contact lens wearers enfilcon A toric lenses can be confidently refit into fanfilcon A toric lenses and can be successful after one month of daily wear.

Official Title
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Performance of Fanfilcon A Toric Lenses After at Least One Month Wearing Enfilcon A Toric Lenses

Conditions
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Astigmatism

Intervention / Treatment
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* Device: fanfilcon A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A person is eligible for inclusion in the study if he/she: Is between 18 and 40 years of age (inclusive) Has had a self-reported eye exam in the last two years Is a habitual soft toric lens wearer Can be successfully fit with study lenses (≥ grade 2 fit acceptance) Has a contact lens spherical prescription between -1.00 to -6.00D with a cylinder between -0.75 and -1.75D (Diopters) (inclusive) Has a spectacle cylinder of at least 0.75D in each eye. Can achieve best corrected spectacle refraction distance visual acuity of 20/25 (0.10 logMAR) or better in each eye. Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses. Has clear corneas and no active ocular disease Has read, understood and signed the information consent letter Has a contact lens refraction that fits within the available parameters of the study lenses Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so) Is willing to comply with the visit schedule. Exclusion Criteria: A person will be excluded from the study if he/she: Has a history of not achieving comfortable CL (Contact Lens) wear (5 days per week; > 8 hours/day) Presents with clinically significant anterior segment abnormalities Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear Presents with slit lamp findings that would contraindicate contact lens wear such as: Pathological dry eye or associated findings Significant pterygium, pinguecula, or corneal scars within the visual axis Neovascularization > 0.75 mm in from of the limbus Anterior uveitis or iritis (or history in past year) Seborrheic eczema of eyelid region, Seborrheic conjunctivitis History of corneal ulcers or fungal infections Poor personal hygiene Has a known history of corneal hypoesthesia (reduced corneal sensitivity) Has aphakia, keratoconus or a highly irregular cornea. Has presbyopia or has dependence on spectacles for near work over the contact lenses. Has undergone corneal refractive surgery. Is participating in any other type of eye related clinical or research study. Is frequently using rewetting/ lubricating eye drops (more than once per day)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: enfilcon A (habitual)<br>All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses. | |
| Active Comparator: fanfilcon A<br>All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses. | Device: fanfilcon A<br>* contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | High contrast distance visual acuity is measured by LogMAR. | baseline, 2 weeks, 1 month | 
| Centration | Lens centration is assessed (optimum, decentration acceptable, decentration unacceptable). | baseline, 2 weeks, 1 month | 
| Corneal Coverage | Corneal coverage will be assessed (yes/no) | baseline, 2 weeks, 1 month | 
| Post-blink Movement | Post-blink lens movement assessed using the following evaluations (0-4): 0=Insufficient, unacceptable, 1=Minimal, acceptable, 2=Optimal, 3=Moderate, acceptable, 4=Excessive, unacceptable) | baseline, 2 weeks, 1 month | 
| Fit Acceptability | Investigator fit acceptability for each lens pair. Scale 0-4: (0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect) | baseline, 2 weeks, 1 month |