Evaluation of Senofilcon A With New UV-blocker on a Neophyte Population

Completed · Not applicable

Conditions studied: Visual Acuity

In brief

This is a 5-visit, single-arm, open-label, dispensing study. Each subject will be bilaterally fit with the test article for approximately 4 weeks of reusable daily wear with lens replacement occurring 2-weeks after initial dispensing. After 4 weeks of study lens wear, subjects will return to their habitual spectacles for one week.

Key facts

Study ID

NCT03742271

Run by

Johnson & Johnson Vision Care, Inc.

People needed

130

Starts

2018-10-30

Expected to finish

2019-03-31

Last updated by the study team

2020-03-13

Who can join

Age: 18 and older, up to 39. 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.
• Between 18 and 39 (inclusive) years of age at the time of screening.
• They are a contact lens 'neophyte'. In this work 'neophyte' is taken to mean any subject who has never been dispensed contact lenses. A subject who had taken part in a non-dispensing clinical study or had been fitted with contact lenses in practice but never went on to actually wear the lenses, is also classified as a 'neophyte'.
• Habitual spectacles must have resulted from an eye exam within the past six months.
• The subject must have worn the updated spectacles for at least two weeks.
• Be a current wearer of prescription spectacles that provide corrected monocular visual acuity of 20/25 or better in each eye.
• The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 D (inclusive) in each eye.
• The subject's refractive cylinder must be -1.00 D or less in each eye.
• Have spherocylindrical best corrected distance Snellen 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
• Currently pregnant or lactating.
• Any active or ongoing systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study.
• Use of systemic medications that have a high likelihood to interfere with contact lens wear (estrogens, antihistamines, anticholinergics, beta-blockers, and psychotropics).
• Any current use of ocular medication.
• Any known hypersensitivity or allergic reaction to any ingredient in Opti-Free PureMoist.
• Any previous or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
• 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 4 slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA slit lamp classification scale.
• Binocular vision abnormality or strabismus.

Where it is running

• Vue Optical Boutique — Jacksonville, Florida, United States
• Atlantic Eye Institute — Jacksonville Beach, Florida, United States
• Sabal Eye Care — Longwood, Florida, United States
• Baker Vision Care — Macclenny, Florida, United States
• Georgia Center for Sight — Greensboro, Georgia, United States
• Advanced Eyecare — Raytown, Missouri, United States
• ABQ Eye Care — Albuquerque, New Mexico, United States
• Sacco Eye Group — Vestal, New York, United States
• ProCare Vision Centers — Granville, Ohio, United States
• Eyecare Professionals of Powell — Powell, Ohio, United States
• Frazier Vision Inc. — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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