Contact Lens Insertion and Removal in a Senior Subject Demographic

Completed · Not applicable

Conditions studied: Visual Acuity

In brief

This will be a pilot, one-visit, open-label, non-dispensing study. Subjects will be given instructions and then attempt to insert and remove a contact lens in each eye.

Key facts

Study ID

NCT03597178

Run by

Johnson & Johnson Vision Care, Inc.

People needed

16

Starts

2018-06-29

Expected to finish

2018-07-12

Last updated by the study team

2019-08-28

Who can join

Age: 60 and older. 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 60 years of age at the time of screening.
• The subject must have normal eyes (i.e., no ocular medications or infections of any type).
• The subject must have best corrected visual acuity (BCVA) of 20/30 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:
• A habitual and adapted wearer of contact lenses (have worn a contact lens at least one time in the past 5 years).
• 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 ocular infection.
• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
• 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)
• 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 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

• VRC-East — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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