Ex-vivo Adhesion of Bacteria to Different Contact Lens Materials

NCT04108286 | Withdrawn FDA Device

• 1 other identifier: CR-6333
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Uptake of Lysozyme on worn lenses

  up to 2-week follow-up

Study Arms (2)

TEST/CONTROL

EXPERIMENTAL

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; Device: DAILIES AQUA COMFORT PLUS

CONTROL/TEST

EXPERIMENTAL

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; Device: DAILIES AQUA COMFORT PLUS

Interventions

1-DAY ACUVUE MOIST DEVICE

TEST

Also known as: 1DAM

CONTROL/TEST; TEST/CONTROL

DAILIES AQUA COMFORT PLUS DEVICE

CONTROL

Also known as: DACP

CONTROL/TEST; TEST/CONTROL

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Between 18 and 45 (inclusive) years of age at the time of screening.
• 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.
• 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
• The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 through -6.00 D in each eye.
• The subject has a best-corrected visual acuity of 20/25 or better in each eye.

You may not qualify if:

• Potential subjects who meet any of the following criteria will be excluded from participating in the study.
• Currently pregnant or breastfeeding.
• Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
• 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.
• Any ocular abnormalities such as entropion, ectropion, extrusions, chalazia, recurrent styes, history of recurrent corneal erosions.
• Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
• Multifocal, toric or extended wear contact lens correction.
• 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 contagious immunosuppressive diseases (e.g., HIV) by self-report.
• Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
• Any ocular infection.
• 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.
• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: September 30, 2019
• Study Start: January 1, 2021
• Primary Completion: January 6, 2021
• Study Completion: January 6, 2021
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share