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N/A N=14 Device Feasibility

Contact Lens Insertion and Removal in a Senior Subject Demographic

Visual Acuity

Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Overall Success Rate of Insertion and Removal of a Contact Lens — 85.7 Percentage of eyes

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
senofilcon A (Device)
Age
Adult, Older Adult · 60+ yrs
Sex
All
Sponsor
Johnson & Johnson Vision Care, Inc.
Primary completion
Jul 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Success Rate of Insertion and Removal of a Contact Lens
85.7

Summary

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.

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03597178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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