Dispensing Study for a New Study Lens

Study Overview
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Brief Summary
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This study investigated the performance criteria over one week of daily wear to determine if the comfilcon A asphere lens (test) performed equivalently to the comfilcon A sphere (control) in terms of measurement and subjective ratings of visual performance.

Detailed Description
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This study was a prospective, single site, daily wear, double masked, randomized bilateral cross over dispensing study of binocular wear of comfilcon A asphere lens (test) and comfilcon A sphere lens (control) over 1 week of daily wear.

Official Title
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Dispensing Study for The Phenacite Project

Conditions
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Myopia

Intervention / Treatment
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* Device: Phenacite
* Device: comfilcon 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: 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 (Diopoter) and -4.00D Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder <-0.75 Has not worn lenses for at least 12 hours before the initial visit Has a subjective response at baseline, which indicates suitability for this study 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 Any systemic disease affecting ocular health Is using any systemic or topical medications that will affect ocular health Has known sensitivity to the diagnostic pharmaceuticals or study products used in this study. Has any ocular pathology or anomaly that would affect the wearing of the lenses Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye Is aphakic Has anisometropia of >1.00 Has undergone corneal refractive surgery Has strabismus Has any ocular amblyopia >= 1line of HC (High Contrast) Visual Acuity Is participating in any other type of eye related clinical or research study Has previously participated in study of the Phenacite lenses

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phenacite Test lens then comfilcon A control lens<br>Participants were randomized to wear Phenacite test lens for one week then cross-over to wear comfilcon A control lens for one week. | Device: Phenacite<br>* contact lens<br>Device: comfilcon A<br>* contact lens<br>|
| Active Comparator: Comfilcon A control lens then Phenacite test Lens<br>Participants were randomized to wear comfilcon A control lens for one week then cross over to Phenacite test lens for one week. | Device: Phenacite<br>* contact lens<br>Device: comfilcon A<br>* contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Visual Acuity (VA) - High Illumination | Distance visual acuity High Illumination was assessed using logMAR | Baseline (after 10 minutes of lens dispense) | 
| Distance Visual Acuity (VA) - High Illumination | Distance visual acuity High Illumination was assessed using logMAR | 1 week | 
| Near Visual Acuity (VA) - High Illumination | Near Visual Acuity (VA) - High Illumination assessed using logMAR | Baseline (after 10 minutes of lens dispense) | 
| Near Visual Acuity (VA) - High Illumination | Near Visual Acuity (VA) - High Illumination assessed using logMAR | 1 week | 
| Distance Visual Acuity (VA) - Low Illumination | Distance Visual Acuity (VA) - Low Illumination assessed using logMAR | Baseline (after 10 minutes of lens dispense) | 
| Distance Visual Acuity (VA) - Low Illumination | Distance Visual Acuity (VA) - Low Illumination assessed using logMAR | 1 week | 
| Near Visual Acuity (VA) - Low Illumination | Near Visual Acuity (VA) - Low illumination assessed using logMAR | Baseline (after 10 minutes of lens dispense) | 
| Near Visual Acuity (VA) - Low Illumination | Near Visual Acuity (VA) - Low illumination assessed using logMAR | 1 week | 
| Quality of Distance Vision | Subjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time) | Baseline (after 10 minutes of lens dispense) | 
| Quality of Distance Vision | Subjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time) | 1 week | 
| Quality of Near Vision | Patient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time | Baseline (After 10 minutes of lens dispense) | 
| Quality of Near Vision | Patient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time | 1 week | 
| Quality of Vision With Digital Device Use | Subjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time) | Baseline (After 10 minutes of lens dispense) | 
| Quality of Vision With Digital Device Use | Subjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time) | 1 week | 
| Quality of Intermediate Vision | Subjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time) | Baseline (After 10 minutes of lens dispense) | 
| Quality of Intermediate Vision | Subjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time) | 1 week | 
| Overall Vision Quality | Subjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time) | Baseline (After 10 minutes of lens dispense) | 
| Overall Vision Quality | Subjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time) | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomicroscopy Findings - Bulbar Hyperemia | Bulbar hyperemia assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps) | 1 week | 
| Biomicroscopy Findings- Limbal Hyperemia | Investigator assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps) | 1 week | 
| Biomicroscopy Findings - Corneal Staining Extent | Investigator Assessment on Biomicroscopy Findings - Corneal Staining Extent on a scale of 0-4 : 0=No staining, 1=1-15% of area, 2=16-30% of area, 3=31-45% of area, 4= >45% of area | 1 week | 
| Ghosting - Distance Vision | Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable | 1 week | 
| Ghosting - Near Vision | Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable | 1 week | 
| Overall Comfort | Patient subjective scoring using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever. | Baseline (After 10 minutes of lens dispense) | 
| Overall Comfort | Patient subjective scoring for overall comfort using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever. | 1 week | 
| Overall Dryness | Patient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time. | Baseline (after 10 minutes of lens dispense) | 
| Overall Dryness | Patient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time. | 1 week | 
| Lens Preference - Overall Vision Preference | Subjective rating of lens preference for overall vision preference (Phenacite, comfilcon A, No preference) | 1 week | 
| Subjective Ratings of Change in Frequency of Tiredness | Subjective rating of change in eye fatigue frequency of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG) | 1 week | 
| Subjective Ratings of Change in Severity of Tiredness | Subjective rating of change in eye fatigue severity of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG) | 1 week | 
| Subjective Ratings of Change in Bothersome Rating for Tiredness | Subjective rating of change in eye fatigue bothersome rating for tiredness assessed using Eye fatigue Experience Questionnaire (EFEG) | 1 week | 
| Subjective Ratings of Change in Frequency of Dryness | Subjective rating of change in eye fatigue frequency of dryness assessed using Eye fatigue Experience Questionnaire (EFEG) | 1 week | 
| Subjective Ratings of Change in Severity of Dryness | Subjective rating of change in eye fatigue severity of dryness assessed using Eye fatigue Experience Questionnaire (EFEG) | 1 week | 
| Subjective Ratings of Change in Bothersome Rating of Dryness | Subjective rating of change in eye fatigue bothersome rating for dryness assessed using Eye fatigue Experience Questionnaire (EFEG) | 1 week | 
| Subjective Questionnaire Response - Eye Strain | Subjective questionnaire response for  My eyes don't feel strained while wearing these lenses - Agree, Disagree | 1 week | 
| Subjective Questionnaire Response - Eye Feel Good | Subjective questionnaire response for  These lenses make my eyes feel good - Agree, Disagree | 1 week | 
| Subjective Questionnaire Response - Eye Feel Relaxed | Subjective questionnaire response for  These lenses make my eyes feel relaxed - Agree, Disagree | 1 week | 
| Subjective Questionnaire Response - Vision | Subjective questionnaire response for  These lenses help my vision - Agree, Disagree | 1 week | 
| Subjective Questionnaire Response - Eye Tired | Subjective questionnaire response for  These lenses make my eyes feel less tired - Agree, Disagree | 1 week |