Clinical trial NCT03597178: Contact Lens Insertion and Removal in a Senior Subject Demographic
Official title: Contact Lens Insertion and Removal in a Senior Subject Demographic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-24
Enrollment: 16
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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:

  1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. Must be at least 60 years of age at the time of screening.
  4. The subject must have normal eyes (i.e., no ocular medications or infections of any type).
  5. 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:

  1. A habitual and adapted wearer of contact lenses (have worn a contact lens at least one time in the past 5 years).
  2. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
  3. Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
  4. Any ocular infection.
  5. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  6. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
  7. History of binocular vision abnormality or strabismus.
  8. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).
  9. Suspicion of or recent history of alcohol or substance abuse.
  10. History of serious mental illness.
  11. History of seizures.
  12. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
  13. 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
  14. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale
  15. 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.

Primary outcomes:
measure: Overall Success Rate of Insertion and Removal of a Contact Lens
timeFrame: Lens insertion and Removal, up to 2-Hours
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: VRC-East
state: Florida
Study officials:
affiliation: Johnson & Johnson Vision Care, Inc.
name: Brian Pall, OD, MS, FAAO
role: STUDY_DIRECTOR
References: