One Week Assessment of The Phenacite Lens

Not Applicable

Completed

Conditions: Myopia

Interventions: Device: Phenacite (Test) contact lens
Device: comfilcon A contact lens

Registration Number: NCT02553395

Lead Sponsor: Coopervision, Inc.

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Phenacite contact lens	Phenacite (Test) contact lens	Study Test Contact Lens
comfilcon A contact lens	comfilcon A contact lens	Control Contact Lens

Primary Outcome Measures

Name	Time	Method
Binocular Distance Visual Acuity (VA) -High Illumination High Contrast	1 week	Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter)
Binocular Near Visual Acuity (VA) - High Illumination High Contrast	1-week	Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter)
Subjective Ratings for Intermediate Quality of Vision	1 week	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)
Subjective Ratings for Near Quality of Vision	1 week	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)
Binocular Distance Visual Acuity (VA) - High Illumination High Contrast	Baseline - After 5 minutes of lens settling	Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter)
Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast	1 week	Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)
Binocular Near Visual Acuity (VA) - Low Illumination High Contrast	1week	Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)
Subjective Ratings for Distance Quality of Vision	1 week	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)

Secondary Outcome Measures

Name	Time	Method
Post Blink Movement -	Baseline (After 5 minutes of lens dispense)	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)
Lens Mobility Rating	1 week	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
Subjective Lens Preference - Distance Vision	1 week	Patient subjective preference: Phenacite lens, comfilcon A or No Preference
Post Blink Movement	1 week	Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
Subjective Lens Preference -Overall Vision Preference	1 week	Patient subjective preference: Phenacite test lens, comfilcon A or No Preference
Subjective Lens Preference - Comfort	1 week	Patient subjective preference: Phenacite test lens, comfilcon A or No Preference
Subjective Overall Lens Preference	1 week	Patient subjective overall preference: Phenacite test lens, comfilcon A or No Preference
Push - Up Test for Lens Tightness	1 week	Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement
Overall Lens Fit Acceptance	1 week	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

Trial Locations

Locations (1): Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
🇺🇸
Bloomington, Indiana, United States