Dispensing Study for the Phenacite Project

CooperVision

Status: Completed

Conditions: Ametropia

Treatments: Device: comfilcon A; Device: Phenacite

Study type: Interventional

Funder types: Industry

Identifiers

NCT02436005

CV-15-16

Details and patient eligibility

About

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.

Full description

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

Enrollment: 25 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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25 participants in 2 patient groups

Phenacite

Experimental group

Description:

Subjects will be randomized to wear the Phenacite contact lenses binocularly.

Treatment:

Device: Phenacite

Device: comfilcon A

comfilcon A

Active Comparator group

Description:

Subjects will be randomized to wear the comfilcon A contact lenses binocularly.

Treatment:

Device: Phenacite

Device: comfilcon A