Clinical Evaluation of Approved and Investigational Contact Lenses

Johnson & Johnson (J&J)

Status: Completed

Conditions: Visual Disorder

Treatments: Device: Investigational Contact Lenses (Test); Device: Marketed Contact Lenses (Control)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02669095

CR-5796

Details and patient eligibility

About

This study is a multi-site, 5-visit dispensing, bilateral double-arm parallel group design, double-masked clinical trial using an investigational contact lens and a marketed contact lens. The objective is to evaluate comfort of the contact lenses when worn on a daily wear modality.

Enrollment: 150 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
• The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
• The subject must be between 18 to 40 years of age at the time of consent.
• The subject's vertexed spherical equivalent distance refraction must be in the range of +8.00 to -12.00 in each eye.
• Subject wears habitual contact lenses a minimum of 4 days per week, eight hours per day.
• The subject must have best corrected visual acuity of 20/30 or better in each eye.
• The subject must be a habitual frequent replacement daily wear spherical silicone hydrogel soft contact lens wearer in both eyes.
• The subject must be able to wear contact lenses for a minimum of 8 hours each day during the study.
• The subject must have normal eyes (i.e., no ocular medications or infections of any type).

Exclusion criteria

• Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
• Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
• Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
• Any known sensitive/allergic to Ingredients of OPTI-FREE® PureMoist® solution.
• Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.
• Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.).
• Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
• Any ocular infection.
• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
• Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Arm 1 (Test Lens)

Experimental group

Description:

Subjects will be dispensed the Investigational Contact Lenses (Test) to be worn as daily wear.

Treatment:

Device: Investigational Contact Lenses (Test)

Arm 2 (Control Lens)

Active Comparator group

Description:

Subjects will be dispensed the Marketed Contact Lenses (Control) to be worn as daily wear.

Treatment:

Device: Marketed Contact Lenses (Control)