Dispensing Study for a New Study Lens

Not Applicable

Completed

Conditions: Myopia

Interventions: Device: Phenacite
Device: comfilcon A

Registration Number: NCT02642991

Lead Sponsor: Coopervision, Inc.

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 44

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Phenacite Test lens then comfilcon A control lens	comfilcon A	Participants were randomized to wear Phenacite test lens for one week then cross-over to wear comfilcon A control lens for one week.
Comfilcon A control lens then Phenacite test Lens	Phenacite	Participants were randomized to wear comfilcon A control lens for one week then cross over to Phenacite test lens for one week.
Phenacite Test lens then comfilcon A control lens	Phenacite	Participants were randomized to wear Phenacite test lens for one week then cross-over to wear comfilcon A control lens for one week.
Comfilcon A control lens then Phenacite test Lens	comfilcon A	Participants were randomized to wear comfilcon A control lens for one week then cross over to Phenacite test lens for one week.

Primary Outcome Measures

Name	Time	Method
Overall Vision Quality	1 week	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)
Near Visual Acuity (VA) - Low Illumination	1 week	Near Visual Acuity (VA) - Low illumination assessed using logMAR
Near Visual Acuity (VA) - High Illumination	1 week	Near Visual Acuity (VA) - High Illumination assessed using logMAR
Distance Visual Acuity (VA) - Low Illumination	1 week	Distance Visual Acuity (VA) - Low Illumination assessed using logMAR
Quality of Intermediate Vision	1 week	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)
Quality of Vision With Digital Device Use	1 week	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)
Distance Visual Acuity (VA) - High Illumination	1 week	Distance visual acuity High Illumination was assessed using logMAR
Quality of Distance Vision	1 week	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)
Quality of Near Vision	1 week	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

Secondary Outcome Measures

Name	Time	Method
Subjective Ratings of Change in Severity of Tiredness	1 week	Subjective rating of change in eye fatigue severity of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)
Biomicroscopy Findings- Limbal Hyperemia	1 week	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)
Biomicroscopy Findings - Corneal Staining Extent	1 week	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
Overall Dryness	1 week	Patient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time.
Lens Preference - Overall Vision Preference	1 week	Subjective rating of lens preference for overall vision preference (Phenacite, comfilcon A, No preference)
Subjective Ratings of Change in Frequency of Tiredness	1 week	Subjective rating of change in eye fatigue frequency of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)
Overall Comfort	1 week	Patient subjective scoring for overall comfort using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever.
Subjective Questionnaire Response - Vision	1 week	Subjective questionnaire response for " These lenses help my vision" - Agree, Disagree
Biomicroscopy Findings - Bulbar Hyperemia	1 week	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)
Ghosting - Near Vision	1 week	Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable
Subjective Ratings of Change in Severity of Dryness	1 week	Subjective rating of change in eye fatigue severity of dryness assessed using Eye fatigue Experience Questionnaire (EFEG)
Subjective Questionnaire Response - Eye Feel Good	1 week	Subjective questionnaire response for " These lenses make my eyes feel good" - Agree, Disagree
Subjective Questionnaire Response - Eye Tired	1 week	Subjective questionnaire response for " These lenses make my eyes feel less tired" - Agree, Disagree
Subjective Ratings of Change in Frequency of Dryness	1 week	Subjective rating of change in eye fatigue frequency of dryness assessed using Eye fatigue Experience Questionnaire (EFEG)
Subjective Questionnaire Response - Eye Strain	1 week	Subjective questionnaire response for " My eyes don't feel strained while wearing these lenses" - Agree, Disagree
Subjective Questionnaire Response - Eye Feel Relaxed	1 week	Subjective questionnaire response for " These lenses make my eyes feel relaxed" - Agree, Disagree
Subjective Ratings of Change in Bothersome Rating of Dryness	1 week	Subjective rating of change in eye fatigue bothersome rating for dryness assessed using Eye fatigue Experience Questionnaire (EFEG)
Ghosting - Distance Vision	1 week	Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable
Subjective Ratings of Change in Bothersome Rating for Tiredness	1 week	Subjective rating of change in eye fatigue bothersome rating for tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)

Trial Locations

Locations (3): CORL, Indiana University
🇺🇸
Bloomington, Indiana, United States
University of California
🇺🇸
Berkeley, California, United States
Center for Contact Lens Research, University of Waterloo
🇨🇦
Waterloo, Ontario, Canada