Evaluation of Prototype Lenses With Experimental UV/HEV Blocker

Completed · Not applicable

Conditions studied: Visual Acuity

In brief

This is a bilateral, 2-week dispensing, randomized, controlled, subject-masked, 2×2 crossover study to evaluate the clinical performance of prototype contact lenses with experimental UV/HEV-blocker.

Key facts

Study ID

NCT04885296

Run by

Johnson & Johnson Vision Care, Inc.

People needed

228

Starts

2021-05-10

Expected to finish

2021-08-09

Last updated by the study team

2022-09-01

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:
• 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.
• Be between 18 and 39 (inclusive) years of age at the time of screening.
• By self-report, habitually wear spherical silicone hydrogel soft contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days.
• Have a habitual contact lens prescription that is current within the prior 6 months, and they must have worn that prescription for at least 2 weeks prior to entering the study.
• The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 through -6.00 D (except -5.00 D) in both eyes.
• The subject's refractive cylinder must be 1.00 D or less.
• 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:
• Be currently pregnant or lactating.
• Have any ocular or systemic allergies or diseases that may interfere with contact lens wear.
• Have any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable.
• Have any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
• Be currently wearing lenses in a monovision, multi-focal, toric, or extended wear modality.
• Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment.
• Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
• Have a history of binocular vision abnormality or strabismus.
• Have any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.
• Have 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.
• Have any ocular infection.
• Have any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
• Have entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.

Where it is running

• Dr. James Weber & Associates, PA — Jacksonville, Florida, United States
• Flora Chen Poveda, OD, PA — Orange Park, Florida, United States
• Tallahassee Eye Center — Tallahassee, Florida, United States
• Visual Eyes — Roswell, Georgia, United States
• Birmingham Vision Care — Bloomfield Township, Michigan, United States
• Complete Eye Care of Medina — Medina, Minnesota, United States
• Dr. Debbie H. Kim, OD — Closter, New Jersey, United States
• Professional Vision Care, Inc. — Westerville, Ohio, United States
• Optometry Group, LLC — Memphis, Tennessee, United States
• Gulf Coast Vision Center, Inc. — Houston, Texas, United States
• Frazier Vision, Inc. — Tyler, Texas, United States
• Botetourt Eyecare, LLC — Salem, Virginia, United States

Full record on ClinicalTrials.gov

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