Dispensing Study for a New Study Lens

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: Phenacite; Device: comfilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02642991

CV-15-41

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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44 participants in 2 patient groups

Phenacite Test lens then comfilcon A control lens

Experimental group

Description:

Participants were randomized to wear Phenacite test lens for one week then cross-over to wear comfilcon A control lens for one week.

Treatment:

Device: comfilcon A

Device: Phenacite

Comfilcon A control lens then Phenacite test Lens

Active Comparator group

Description:

Participants were randomized to wear comfilcon A control lens for one week then cross over to Phenacite test lens for one week.

Treatment:

Device: comfilcon A

Device: Phenacite