Contact Lens Insertion and Removal in a Senior Subject Demographic

NCT ID: NCT03597178

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-29
• Study Completion Date: 2018-07-12

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.

Conditions

Visual Acuity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

senofilcon A

Subjects that are of at least 60 years of age and non-habitual contact lens wearers will receive instructions to insert and remove a contact lens from each eye.

Group Type: EXPERIMENTAL

senofilcon A

Intervention Type: DEVICE

ACUVUE OASYS® 1-DAY with HydraLuxe™ Technology

Interventions

senofilcon A

ACUVUE OASYS® 1-DAY with HydraLuxe™ Technology

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Pall, OD, MS, FAAO

Role: STUDY_DIRECTOR

Johnson & Johnson Vision Care, Inc.

Locations

VRC-East

Jacksonville, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-6289

Identifier Type: -

Identifier Source: org_study_id