Clinical Evaluation of Approved Contact Lenses

This is a 4-week, randomized, double-masked study where subjects will wear bilaterally test and control lenses in random succession. The objective is to evaluate materials from different suppliers.

Study Overview

• Status: Completed
• Conditions: Visual Acuity
• Intervention / Treatment: Device: Test Contact Lens; Device: Control Contact Lens

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
      • University of Alabama at Birmingham
  • Florida
    • Jacksonville, Florida, United States
      • Eye Elements Eyecare
    • Sarasota, Florida, United States
      • Golden Vision
  • Kansas
    • Neodesha, Kansas, United States
      • Advantage Eyecare Associates, LLC
  • Missouri
    • Raytown, Missouri, United States
      • Advanced Eyecare, PC
  • Ohio
    • Westerville, Ohio, United States
      • Professional Vision Care
  • Virginia
    • Roanoke, Virginia, United States
      • Timothy R. Poling, OD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. The subject must be at least 18 and not more than 70 years of age (including 70).
4. The subject's refractive cylinder must be < 0.75 Diopters (D) in each eye.
5. The subject must have best corrected visual acuity of 20/25 or better in each eye.
6. The subject must be a habitual and adapted wearer of ACUVUE® OASYS® brand contact lens in both eyes (at least 1 month of daily wear).
7. The subject must have normal eyes (i.e., no ocular medications or infections of any type).
8. The subject's required spherical contact lens prescription must be in the range of -1.00 D to -6.00 D in each eye.

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia.
5. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
6. 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.
7. Any known hypersensitivity or allergic reaction to OPTI-FREE® PureMoist® Contact Lens Solution.
8. Any ocular infection.
9. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
10. Monovision or multi-focal contact lens correction.
11. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
12. History of binocular vision abnormality or strabismus.
13. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).
14. Suspicion of or recent history of alcohol or substance abuse.
15. History of serious mental illness.
16. History of seizures.
17. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test / Control Sequence; Subjects will be dispensed the Test Contact Lens to wear for two weeks, to be worn in a daily wear modality, attending a follow-up visit in 12-17 days. At the follow-up visit, subjects will be dispensed the Control Contact Lens to wear for two weeks, to be worn in a daily wear modality.	Device: Test Contact Lens; Other Names: senofilcon A made with material from a new supplier; Device: Control Contact Lens; Other Names: senofilcon A made with material from the current supplier
Active Comparator: Control / Test Sequence; Subjects will be dispensed the Control Contact Lens to wear for two weeks, to be worn in a daily wear modality, attending a follow-up visit in 12-17 days. At the follow-up visit, subjects will be dispensed the Test Contact Lens to wear for two weeks, to be worn in a daily wear modality.	Device: Test Contact Lens; Other Names: senofilcon A made with material from a new supplier; Device: Control Contact Lens; Other Names: senofilcon A made with material from the current supplier

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contact Lens Wearing Time	Contact lens wearing time was collected for each subject at the 2-week follow-up evaluation. The average contact lens wearing time in hours was reported for each lens.	2-week follow-up
Visual Acuity (LogMAR)	Distance Visual Acuity (LogMAR) was assessed using an ETDRS chart at the 2-week follow-up for each subject and eye for 2 conditions, Bright low contrast and Dim high contrast. The average visual acuity (LogMAR) for each condition and lens was reported.	2-week Follow-up

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: March 1, 2016
• First Submitted That Met QC Criteria: March 1, 2016
• First Posted (Estimate): March 4, 2016

Study Record Updates

• Last Update Posted (Actual): July 12, 2017
• Last Update Submitted That Met QC Criteria: June 15, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CR-5809

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes