The Effects of Contact Lenses With Experimental Dye on Visual Function

Completed · Not applicable

Conditions studied: Ametropia

In brief

This is a single-site, two-visit, contralateral, non-dispensing, randomized, controlled and subject-masked study to measure potential benefits of the new UV blocker.

Key facts

Study ID

NCT03556579

Run by

Johnson & Johnson Vision Care, Inc.

People needed

62

Starts

2018-05-15

Expected to finish

2018-09-20

Last updated by the study team

2019-11-18

Who can join

Age: 18 and older, up to 65. 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 65 (inclusive) years of age at the time of screening.
• Be a current spherical soft silicone hydrogel contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week wear time over the last 30 days by self-report.
• The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 through -4.50 D in each eye.
• The subject has a best corrected visual acuity of 20/25 or better in each eye.

You may not qualify if…

• Currently pregnant or breastfeeding.
• Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
• 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.
• Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
• Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
• Multifocal, toric or extended wear 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 contagious immunosuppressive diseases (e.g., HIV) by self-report.
• Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
• Any ocular infection.
• 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.

Where it is running

• Georgia Center for Sight — Statesboro, Georgia, United States

Full record on ClinicalTrials.gov

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