Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: samfilcon A; Device: comfilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02542072

EX-MKTG-59 (VISA-406)

Details and patient eligibility

About

The purpose of this study is to compare the subjective performance of comfilcon A lens against samfilcon A lens after 4 weeks of reusable lens wear.

Full description

This will be a 90 subject, randomized, bilateral, subject-masked, dispensing, cross-over study comparing comfilcon A versus samfilcon A lenses over 8 weeks of daily wear (2 x 4-weeks). Both eyes will wear the same lens (test or control) for 4 weeks in a randomized fashion. Subjects will be masked to lens type and investigators will be masked to the lens codes.

Enrollment: 90 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• Spherical distance Contact Lens prescription between -1.00 and -6.00D or +1.00 to +4.00D in both eyes (inclusive)
• Adapted soft Contact Lens wearers (i.e. >1 month), daily disposable and reusable lens wearers.
• Spectacle cylinder 0.75D in both eyes.
• Correctable to 6/9 (20/30) in both eyes
• Be between 18 and 50 years of age (inclusive)
• Able to read, comprehend and sign an informed consent
• Own a mobile phone and be willing to respond to Short Message Service (SMS) survey
• Willing to comply with the wear and study visit schedule

Exclusion:

• Existing Biofinity or Ultra wearers
• Any active corneal infection, injury or inflammation
• Systemic or ocular allergies, which might interfere with Contact Lens wear
• Systemic disease, which might interfere with Contact Lens wear
• Ocular disease, which might interfere with Contact Lens wear
• Strabismus or amblyopia
• Subjects who have undergone corneal refractive surgery
• Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
• Pregnant or lactating
• Use of systemic/topical medication contraindicating Contact Lens wear
• Diabetic
• Site employees or family members of site employees

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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90 participants in 2 patient groups

comfilcon A

Active Comparator group

Description:

Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.

Treatment:

Device: comfilcon A

samfilcon A

Active Comparator group

Description:

Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.

Treatment:

Device: samfilcon A