Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04108286




Registration number
NCT04108286
Ethics application status
Date submitted
26/09/2019
Date registered
30/09/2019
Date last updated
11/05/2021

Titles & IDs
Public title
Ex-vivo Adhesion of Bacteria to Different Contact Lens Materials
Scientific title
Ex-vivo Adhesion of Bacteria to Different Contact Lens Materials
Secondary ID [1] 0 0
CR-6333
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Visual Acuity 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - 1-DAY ACUVUE MOIST
Treatment: Devices - DAILIES AQUA COMFORT PLUS

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).

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).


Treatment: Devices: 1-DAY ACUVUE MOIST
TEST

Treatment: Devices: DAILIES AQUA COMFORT PLUS
CONTROL
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Bacterial adhesion of clinical isolates of P. aeruginosa
Timepoint [1] 0 0
up to 2-week follow-up
Secondary outcome [1] 0 0
Uptake of Lysozyme on worn lenses
Timepoint [1] 0 0
up to 2-week follow-up

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/01/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
6/01/2021
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Johnson & Johnson Vision Care, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT04108286
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04108286