Dispensing Study for the Phenacite Project

Study Overview
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Brief Summary
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Dispensing Study for the Phenacite Project. The investigational test lens was not the final optical design and the study was not used for design validation.

Detailed Description
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Evaluate the objective and patient-reported visual acceptability of the Phenacite contact lens.

Official Title
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Dispensing Study for the Phenacite Project

Conditions
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Ametropia

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: 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 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: 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 Visual Acuity Is participating in any other type of eye related clinical or research study Has participated in study CV-14-32.

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<br>Subjects will be randomized to wear the Phenacite contact lenses binocularly. | Device: Phenacite<br>* Subjects will be randomized to wear the Phenacite contact lenses binocularly.<br>Device: comfilcon A<br>* Subjects will be randomized to wear the comfilcon A contact lenses binocularly.<br>|
| Active Comparator: comfilcon A<br>Subjects will be randomized to wear the comfilcon A contact lenses binocularly. | Device: Phenacite<br>* Subjects will be randomized to wear the Phenacite contact lenses binocularly.<br>Device: comfilcon A<br>* Subjects will be randomized to wear the comfilcon A contact lenses binocularly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Ratings of Lens Comfort | Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt) | Baseline (after 15 minutes of lens dispense) | 
| Subjective Ratings of Lens Comfort | Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt) | 2 Weeks | 
| Over Refraction for Optimized Distance Acuity | Over Refraction for optimized distance acuity measured using logMAR | 2 weeks | 
| Binocular Distance Visual Acuity - High Illumination High Contrast | Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR | Baseline (after 5 minutes of lens dispense) | 
| Binocular Distance Visual Acuity - High Illumination High Contrast | Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR | 2 weeks | 
| Binocular Distance Visual Acuity - Low Illumination High Contrast | Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR | Baseline (after 5 minutes of lens dispense) | 
| Binocular Distance Visual Acuity - Low Illumination High Contrast | Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR | 2 weeks | 
| Binocular Near Visual Acuity - High Illumination High Contrast | Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR | Baseline (after 5 minutes of lens dispense) | 
| Binocular Near Visual Acuity - High Illumination High Contrast | Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR | 2 weeks | 
| Binocular Near Visual Acuity - Low Illumination High Contrast | Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR | Baseline (after 5 minutes of lens dispense) | 
| Binocular Near Visual Acuity - Low Illumination High Contrast | Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Fit - Post Blink Movement | Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps) | Baseline (after 15 minutes of lens dispense) | 
| Lens Fit - Post Blink Movement | Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps) | 2 weeks | 
| 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 15 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 | 2 weeks | 
| 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 15 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 | 2 weeks | 
| 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 15 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 | 2 weeks | 
| Subjective Ratings for Vision Quality - Distance Vision | Patient subjective scoring using 0-100 continuous scale 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 | Baseline (after 15 minutes of lens dispense) | 
| Subjective Ratings for Vision Quality - Distance Vision | Patient subjective scoring using 0-100 continuous scale 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 | 2 weeks | 
| Subjective Ratings for Vision Quality - Near Vision | Patient subjective scoring using 0-100 continuous scale 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 | Baseline (after 15 minutes of lens dispense) | 
| Subjective Ratings for Vision Quality - Near Vision | Patient subjective scoring using 0-100 continuous scale 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 | 2 weeks | 
| Subjective Ratings for Vision Quality - Computer Vision | Patient subjective scoring using 0-100 continuous scale for Computer 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 | Baseline (after 15 minutes of lens dispense) | 
| Subjective Ratings for Vision Quality - Computer Vision | Patient subjective scoring using 0-100 continuous scale for Computer 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 | 2 weeks | 
| Subjective Ratings for Vision Quality - Overall Vision | Patient subjective scoring using 0-100 continuous scale for Overall 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 | Baseline (after 15 minutes of lens dispense) | 
| Subjective Ratings for Vision Quality - Overall Vision | Patient subjective scoring using 0-100 continuous scale for Overall 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 | 2 weeks | 
| Corneal Staining Extent | Corneal staining extent was assessed 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 | 2 weeks | 
| Conjunctival Staining | Conjunctival staining was assessed on a scale of 0-4, 0.50 steps (0-None, 1 - Minimal diffuse punctuate, 2- Coalescent Punctuate, 3- confluent, 4- Deep confluent | 2 weeks |