One Week Assessment of The Phenacite Lens

Study Overview
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Brief Summary
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This study will investigate performance criteria over one week of daily wear to determine if the Study Test contact lens performs equivalently to the comfilcon A contact lenses in terms of subjective ratings and of visual performance. The study test lens was not the final optical design and the study results were not used for the design validation.

Detailed Description
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This will be double-masked, randomized, bilateral crossover study comparing the Study Test lens against the comfilcon A control lens, each worn over one week of daily wear. The study test lens was not the final optical design and the study results were not used for the design validation.

Official Title
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One Week Assessment of The Phenacite Lens

Conditions
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Myopia

Intervention / Treatment
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* Device: Phenacite (Test) contact lens
* Device: comfilcon A contact lens


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: Oculo-visual examination in the last two years Between 18 and 35 years of age and has full legal capacity to volunteer Has read and understood the informed consent letter Is willing and able to follow instructions and maintain the appointment schedule Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected Currently wears, or has previously successfully worn, soft contact lenses between -1.00D (Diopter) and -4.50D Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder <-0.75 Currently spends a minimum of 4 hours a day; 5 days a week on digital devices and can replicate this time during the study period Is willing and able to wear the study contact lenses a minimum of 10 hours per day; 5 days a week. 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 participating in any other type of eye related clinical or research study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phenacite contact lens<br>Study Test Contact Lens | Device: Phenacite (Test) contact lens<br> <br> |
| Active Comparator: comfilcon A contact lens<br>Control Contact Lens | Device: comfilcon A contact lens<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular Distance Visual Acuity (VA) - High Illumination High Contrast | Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter) | Baseline - After 5 minutes of lens settling | 
| Binocular Distance Visual Acuity (VA) -High Illumination High Contrast | Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter) | 1 week | 
| Binocular Near Visual Acuity (VA) - High Illumination High Contrast | Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter) | Baseline - after 5 minutes of lens dispense | 
| Binocular Near Visual Acuity (VA) - High Illumination High Contrast | Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter) | 1-week | 
| Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast | Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter) | Baseline (After 5 minutes of lens settling) | 
| Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast | Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter) | 1 week | 
| Binocular Near Visual Acuity (VA) - Low Illumination High Contrast | Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter) | Baseline (after 5 minutes of lens settling) | 
| Binocular Near Visual Acuity (VA) - Low Illumination High Contrast | Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter) | 1week | 
| Subjective Ratings for Distance Quality of Vision | Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Distance Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time) | 1 week | 
| Subjective Ratings for Intermediate Quality of Vision | Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Intermediate Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time) | 1 week | 
| Subjective Ratings for Near Quality of Vision | Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Near Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time) | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Blink Movement - | Post blink movement was assessed by the investigator by the amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps) | Baseline (After 5 minutes of lens dispense) | 
| Post Blink Movement | Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps) | 1 week | 
| Push - Up Test for Lens Tightness | Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement | Baseline (After 5 minutes of lens dispense) | 
| Push - Up Test for Lens Tightness | Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement | 1 week | 
| Lens Mobility Rating | Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps | Baseline (after 5 minutes of lens dispense) | 
| Lens Mobility Rating | Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps | 1 week | 
| Overall Lens Fit Acceptance | Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps | Baseline (After 5 minutes of lens dispense) | 
| Overall Lens Fit Acceptance | Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn,, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps | 1 week | 
| Subjective Lens Preference - Distance Vision | Patient subjective preference: Phenacite lens, comfilcon A or No Preference | 1 week | 
| Subjective Lens Preference -Overall Vision Preference | Patient subjective preference: Phenacite test lens, comfilcon A or No Preference | 1 week | 
| Subjective Lens Preference - Comfort | Patient subjective preference: Phenacite test lens, comfilcon A or No Preference | 1 week | 
| Subjective Overall Lens Preference | Patient subjective overall preference: Phenacite test lens, comfilcon A or No Preference | 1 week |