Status:
WITHDRAWN
Ex-vivo Adhesion of Bacteria to Different Contact Lens Materials
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Visual Acuity
Eligibility:
All Genders
18-45 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04108286
Start Date
January 1 2021
End Date
January 6 2021
Last Update
May 11 2021
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