Ex-vivo Adhesion of Bacteria to Different Contact Lens Materials

NCT ID: NCT04108286

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2021-01-06

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

1-DAY ACUVUE MOIST

Intervention Type: DEVICE

TEST

DAILIES AQUA COMFORT PLUS

Intervention Type: DEVICE

CONTROL

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).

Group Type: EXPERIMENTAL

1-DAY ACUVUE MOIST

Intervention Type: DEVICE

TEST

DAILIES AQUA COMFORT PLUS

Intervention Type: DEVICE

CONTROL

Interventions

1-DAY ACUVUE MOIST

TEST

Intervention Type: DEVICE

DAILIES AQUA COMFORT PLUS

CONTROL

Intervention Type: DEVICE

Other Intervention Names

1DAM; DACP

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. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CR-6333

Identifier Type: -

Identifier Source: org_study_id