Daily Disposable Dispensing Clinical Trial of Test Lens Against Stenfilcon A Lens

Study Overview
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Brief Summary
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The purpose of this study is to investigate the overall clinical performance of the test daily disposable stenfilcon A lens with solution additive (test) compared to the stenfilcon A lens (control).

Detailed Description
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This will be, prospective, multicenter, double-masked, randomized, bilateral, 1 month cross-over, dispensing study comparing the test lens against the stenfilcon A control lens with a study duration of approximately two months. Each subject will be randomized to wear either the test or control as a matched pair first and subjects will be randomized based on the order in which the subject is enrolled and qualified into the study.

Official Title
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Daily Disposable Dispensing Clinical Trial of Test Lens Against Stenfilcon A Lens

Conditions
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Myopia

Intervention / Treatment
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* Device: stenfilcon A lens with solution additive (test)
* Device: stenfilcon A lens (control)


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: Has had a self-reported oculo-visual examination in the last two years. Is at least 18 years of age and has full legal capacity to volunteer. Has read and understood the information consent letter. Is willing and able to follow instructions and maintain the appointment schedule. Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected. Must achieve 20/30 or better (in each eye) with study lenses Requires spectacle lens powers between -0.75 and -6.50 diopters sphere (0.25D steps). Has no more than 0.75 diopters of refractive astigmatism. Currently wears soft contact lenses. Have clear corneas and no active ocular disease. Has not worn lenses for at least 12 hours before the examination 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, active neovascularization or any central corneal scars. Is aphakic. Has undergone corneal refractive surgery. Is pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit). Have taken part in any other contact lens or care solution clinical trial or research, within one week prior to starting this study.

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stenfilcon A lens with solution additive (test)<br>Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. | Device: stenfilcon A lens with solution additive (test)<br>* silicone hydrogel lens<br>Device: stenfilcon A lens (control)<br>* contact lens<br>|
| Active Comparator: stenfilcon A lens (control)<br>Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. | Device: stenfilcon A lens with solution additive (test)<br>* silicone hydrogel lens<br>Device: stenfilcon A lens (control)<br>* contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Ratings on Comfort | Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable | Baseline | 
| Subjective Ratings on Comfort | Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable | 1 Week | 
| Subjective Ratings on Comfort | Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable | 1 Month | 
| Vision Satisfaction | Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree | Baseline | 
| Vision Satisfaction | Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree | 1 week | 
| Vision Satisfaction | Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree | 1 Month | 
| Visual Acuity On High Illumination High Contrast | Visual acuity is assessed on high illumination high contrast logMAR charts for test and control lenses. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart. | Baseline | 
| Visual Acuity On High Illumination High Contrast | Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart. | 1 Week | 
| Visual Acuity On High Illumination High Contrast | Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart. | 1 Month | 
| Visual Acuity On Low Illumination High Contrast | Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart. | Baseline | 
| Visual Acuity On Low Illumination High Contrast | Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart. | 1 Week | 
| Visual Acuity On Low Illumination High Contrast | Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart. | 1 Month | 
| Overall Corneal Staining | Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe. | One Week | 
| Overall Corneal Staining | Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe. | One Month | 
| Conjunctival Staining | Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent | 1 Week | 
| Conjunctival Staining | Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent | 1 Month | 
| Bulbar Hyperemia | Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection) | 1 Week | 
| Bulbar Hyperemia | Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection) | 1 Month | 
| Limbal Hyperemia | Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection) | 1 Week | 
| Limbal Hyperemia | Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection) | 1 Month | 
| Palpebral Hyperemia | Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection) | 1 Week | 
| Palpebral Hyperemia | Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection) | 1 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Fit Acceptance | Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum. | Baseline | 
| Lens Fit Acceptance | Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum. | 1 week | 
| Lens Fit Acceptance | Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum. | 1 Month | 
| Handling Satisfaction | Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree | 1 week | 
| Handling Satisfaction | Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree | 1 Month | 
| Lens Surface - Wettability | Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent | Baseline | 
| Lens Surface - Wettability | Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent | 1 Week | 
| Lens Surface - Wettability | Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent | 1 Month | 
| Lens Surface - Deposits | Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface. | Baseline | 
| Lens Surface - Deposits | Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface. | 1 week | 
| Lens Surface - Deposits | Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface. | 1 Month | 
| Subjective Ratings on Dryness | Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry | Baseline | 
| Subjective Ratings on Dryness | Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry | 1 week | 
| Subjective Ratings on Dryness | Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry | 1 Month |