Ex-vivo Adhesion of Bacteria to Different Contact Lens Materials

This is a single-site, 4-visit, contralateral, dispensing, open-label, randomized study. Each eligible subject will be randomized into one of two sequence groups to wear two lens types contralaterally (Test on the right eye and Control on left eye or vice versa).

Study Overview

• Status: Withdrawn
• Conditions: Visual Acuity
• Intervention / Treatment: Device: 1-DAY ACUVUE MOIST; Device: DAILIES AQUA COMFORT PLUS

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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. Between 18 and 45 (inclusive) years of age at the time of screening.
  4. Be a current spherical soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week wear time over the last 30 days by self-report.
  5. Have a pair of spectacles with corrected vision of 20/40 or better in each eye or uncorrected vision is 20/40 or better in each eye
  6. The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 through -6.00 D in each eye.

  7. The subject has a best-corrected visual acuity of 20/25 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. Currently pregnant or breastfeeding.
  2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
  3. Any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable.
  4. Any ocular abnormalities such as entropion, ectropion, extrusions, chalazia, recurrent styes, history of recurrent corneal erosions.
  5. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
  6. Multifocal, toric or extended wear contact lens correction.
  7. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
  8. History of binocular vision abnormality or strabismus.
  9. Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.
  10. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
  11. Any ocular infection.
  12. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the EFRON scale (Appendix G), 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.
  13. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TEST/CONTROL; Eligible subjects that are habitual wearers of spherical soft contact lenses will be randomly assigned to 1 of 2 contralateral lens sequences (Right: TEST/ Left: CONTROL) or (Right: CONTROL/ Left: TEST).	Device: 1-DAY ACUVUE MOIST; TEST; Other Names: 1DAM; Device: DAILIES AQUA COMFORT PLUS; CONTROL; Other Names: DACP
Experimental: CONTROL/TEST; Eligible subjects that are habitual wearers of spherical soft contact lenses will be randomly assigned to 1 of 2 contralateral lens sequences (Right: TEST/ Left: CONTROL) or (Right: CONTROL/ Left: TEST).	Device: 1-DAY ACUVUE MOIST; TEST; Other Names: 1DAM; Device: DAILIES AQUA COMFORT PLUS; CONTROL; Other Names: DACP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial adhesion of clinical isolates of P. aeruginosa	Evaluation of the bacterial adhesion of 2 strains of bacteria, P. aeruginosa, on worn lenses based on the number of viable bacteria on the lens measured in colony forming unit (CFU).	up to 2-week follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uptake of Lysozyme on worn lenses	Uptake of Lysozyme on worn lenses: Evaluation of the uptake of lysozyme between different lens materials of worn lenses based on the clearance zone measured in the nearest (mm).	up to 2-week follow-up

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): January 6, 2021
• Study Completion (Anticipated): January 6, 2021

Study Registration Dates

• First Submitted: September 26, 2019
• First Submitted That Met QC Criteria: September 26, 2019
• First Posted (Actual): September 30, 2019

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 10, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: CR-6333

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

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