Evaluation of Stenfilcon A Versus Etafilcon A

Study Overview
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Brief Summary
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Evaluation of two contact lenses

Detailed Description
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One week dispensing, investigator-masked, randomized, contralateral study comparing the test lens against the control lens. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye simultaneously.

Official Title
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Evaluation of Stenfilcon A Versus Etafilcon A

Conditions
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Myopia

Intervention / Treatment
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* Device: Etafilcon A
* Device: Stenfilcon A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is at least 17 years of age and has full legal capacity to volunteer; Has read and signed an information consent letter; Is willing and able to follow instructions and maintain the appointment schedule; Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses; Has astigmatism less than or equal to -1.00D; Is an adapted soft contact lens wearer; Demonstrates an acceptable fit with the study lenses; Has no active anterior segment disease or known ocular disease. Exclusion Criteria: A person will be excluded from the study if he/she: Has never worn contact lenses before; Has any systemic disease affecting ocular health; Is using any systemic or topical medications that will affect ocular health; Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses; Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye; Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities; Is aphakic; Has undergone corneal refractive surgery; Is participating in any other type of clinical or research study; Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Active Comparator: Etafilcon A<br>Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously | Device: Stenfilcon A<br> <br> |
| Experimental: Stenfilcon A<br>Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously | Device: Etafilcon A<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant's Subjective Rating of Comfort (Questionnaire) | Participants rated their comfort of lenses by subjective questionnaire (un-annotated scale, 0-100, 0=Poor comfort/intolerable, 100=Excellent comfort/cannot be felt) Change over time measured at insertion, After settling, 12-hours, 1-week | Insertion, After Lens settling, 12-hours, 1-week | 
| Participant's Subjective Rating of Dryness (Questionnaire) | Participants rated dryness of the lenses by subjective questionnaire (annotated scale, 0-100, 0=cannot be worn / extremely dry, 100=no dryness experienced at any time) Change over time measured at 12-hours, 1-week | 12-hours, 1-week | 
| Participant's Subjective Rating of Lens Handling for Insertion (Questionnaire) | Participants rated their lens handling experience for lens insertion by questionnaire (un-annotated scale, 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye) Measured at Dispensing | Dispense | 
| Participant's Subjective Rating of Lens Handling for Removal (Questionnaire) | Participants rated their lens handling experience for the lens removal by questionnaire (un-annotated scale, 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye) Change over time measured at 12-hours, 1-week | 12-hours, 1-week | 
| Participant's Subjective Rating of Visual Quality (Questionnaire) | Participants rated visual quality of the lenses by questionnaire (annotated scale, 0-100, 0=extremely poor vision all of the time. Cannot function, 100=excellent vision all of the time) Change over time measured at 12-hours, 1-week | 12-hours, 1-week | 
| Participant's Subjective Rating of Overall Preference (Questionnaire) | Participants rated their overall lens preference by questionnaire. (annotated scale, 0-100, scale normalized to 0=no preference, +50=strongly prefers test lens, -50=strongly prefers control lens). Change over time measured at 12-hours, 1-week | 12-hours, 1-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy) | Investigators assigned a lens surface wettability grade by biomicroscopy assessment (grading scale, 0 to 4, 0=excellent, 4=severely reduced). Change over time measured after lens settling (insertion), after 12-hours wear on the dispense day (12-hours), after a minimum on one hour of lens wear at 1 week (1-week). | Insertion, 12 hours, 1 week | 
| Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy) | Investigators assigned an overall fit acceptance grade by biomicroscopy assessment (grading scale, 0-4, 0=very poor, 4=very good). Change over time measured at insertion, 12-hours, 1-week | Insertion, 12 hours, 1 week | 
| Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen) | Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at normal lighting conditions (high illumination). (logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week. | Insertion | 
| Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen) | Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at low lighting conditions (low illumination). (logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week. | Insertion, 12-hours, 1-week | 
| Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with corneal staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week | Baseline, 12-hours, 1-week | 
| Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) | Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with conjuncitval staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week | Baseline, 12-hours, 1-week |