Evaluation of Etafilcon A Daily Disposable Lenses

NCT ID: NCT02061592

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-03-31

Brief Summary

To evaluate the clinical performance of daily disposable etafilcon A lenses.

Conditions

Myopia

Study Design

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

Study Groups

Etafilcon A Control Lens

etafilcon A

Group Type: ACTIVE_COMPARATOR

etafilcon A

Intervention Type: DEVICE

Etafilcon A Test Lens

etafilcon A

Group Type: EXPERIMENTAL

etafilcon A

Intervention Type: DEVICE

Interventions

etafilcon A

Intervention Type: DEVICE

etafilcon A

Intervention Type: DEVICE

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 at least 18 and not more than 70 years of age.
• The subject's refractive cylinder must be < 1.00 Diopters (D) in each eye.
• The subject must have best corrected visual acuity of 20/25 or better in each eye.
• The subject's required spherical contact lens prescription must be in the range of -0.50 to -7.50 D in each eye.
• The subject must be a habitual and adapted wearer of daily disposable contact lenses in both eyes.
• The subject must self-report their race as Asian
• The subject must have normal eyes (i.e., no ocular medications or infections of any type).
• The subject must demonstrate adequate mobility and 20/30 vision oculus dexter (OD) and oculus sinister (OS) with the study contact lenses.

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 that may interfere with contact lens wear.
• Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia.
• Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser 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.
• Monovision or multi-focal contact lens correction.
• Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
• History of binocular vision abnormality or strabismus.
• Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self report).
• Suspicion of or recent history of alcohol or substance abuse.
• History of serious mental illness.
• History of seizures.
• Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jacksonville, Florida, United States

Honolulu, Hawaii, United States

Kahului, Hawaii, United States

Waipahu, Hawaii, United States

‘Aiea, Hawaii, United States

New York, New York, United States

Houston, Texas, United States

Countries

United States

Other Identifiers

CR-5553

Identifier Type: -

Identifier Source: org_study_id