Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Manufacturing Technology

Completed · Not applicable

Conditions studied: Visual Acuity

In brief

This study is a multi-site, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear both Test and Control lenses in each eye in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods.

Key facts

Study ID

NCT03962790

Run by

Johnson & Johnson Vision Care, Inc.

People needed

95

Starts

2019-05-15

Expected to finish

2019-07-10

Last updated by the study team

2020-08-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Potential subjects must satisfy all of the following criteria to be enrolled in the study:
• The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
• Appear able and willing to adhere to the instructions set forth in this clinical protocol.
• Must be at least 18 and not more than 70 years of age (including 70) at the time of screening.
• The subject must be a habitual and adapted wearer of hydrogel daily disposable brand contact lenses in both eyes (at least 1 month of daily wear).
• The subject must have normal eyes (i.e., no ocular medications or infections of any type).
• The subject's required spherical contact lens prescription must be in the range of -0.50 to -6.00 D in each eye.
• The subject's refractive cylinder must be < 0.75D in each eye.
• The subject must have best corrected visual acuity of 20/25 or better in each eye.

You may not qualify if…

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:
• Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
• Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
• Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
• 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 or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)
• Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion
• Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Food and Drug Administration (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.

Where it is running

• Maitland Vision Center — Maitland, Florida, United States
• Eyecare Associates, LLP — Bloomington, Illinois, United States
• Manhattan Vision Associates — New York, New York, United States
• Sacco Eye Group — Vestal, New York, United States
• Eyecare Professionals of Powell — Powell, Ohio, United States
• Frazier Vision — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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