Clinical Evaluation of Approved and Investigational Contact Lenses

NCT ID: NCT02669095

Last Updated: 2017-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-03-31

Brief Summary

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.

Conditions

Visual Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1 (Test Lens)

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

Group Type: EXPERIMENTAL

Investigational Contact Lenses (Test)

Intervention Type: DEVICE

Arm 2 (Control Lens)

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

Group Type: ACTIVE_COMPARATOR

Marketed Contact Lenses (Control)

Intervention Type: DEVICE

Interventions

Investigational Contact Lenses (Test)

Intervention Type: DEVICE

Marketed Contact Lenses (Control)

Intervention Type: DEVICE

Other Intervention Names

senofilcon C; comfilcon A

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Golden Family Eyecare

Sarasota, Florida, United States

Eye Associates of Winter Park

Winter Park, Florida, United States

Pickens Family Eye Care

Pickens, South Carolina, United States

Total Eye Care PA

Memphis, Tennessee, United States

Countries

United States

Other Identifiers

CR-5796

Identifier Type: -

Identifier Source: org_study_id