N/A
N=14
Clinical Performance of Two Daily Disposable Silicone Hydrogel Contact Lenses
Visual Acuity
Bottom Line
View on ClinicalTrials.gov: NCT05554640 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Proportion of Eyes With Acceptable Lens Fitting — 100; 100 Proportion of eyes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acuvue® Oasys MAX 1-Day (Device); Dailies Total 1 (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Eyes With Acceptable Lens Fitting |
100; 100 | — |
Summary
This is a subject-masked, randomized, bilateral, 2x2 crossover clinical investigation that will assess lens fit acceptance.
Eligibility Criteria
Inclusion Criteria
- 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 40 (inclusive) years of age at the time of screening.
- They agree not to participate in other clinical research while enrolled on this study.
- They have worn the same brand of soft daily disposable silicone hydrogel contact lenses at least eight hours per day for at least four days per week over the past 4 weeks.
- They own a wearable pair of spectacles if needed for distance vision correction (by self-report).
- They can attain a best-corrected logMAR distance visual acuity of at least 0.20 in each eye.
- They have spherical contact lens prescription in the range -1.00 to -6.00 DS (based on the calculated ocular refraction).
- They have up to maximum of 1.00 DC of refractive astigmatism (based on the calculated ocular refraction).
Exclusion Criteria
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Currently pregnant or lactating.
- Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g., rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study or may pose a risk to study personnel.
- They have an ocular disorder which would normally contraindicate contact lens wear.
- They have had cataract surgery.
- They have had corneal refractive surgery.
- They are using any topical medications such as eye drops or ointments.
- Any known hypersensitivity or allergic reaction to sodium fluorescein.
- Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear. See section 9.1 for additional details regarding excluded systemic medications.
- Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrollment.
- Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
- They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- Any Efron Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection), 13. They have a pre-corneal tear film break-up time less than five seconds when evaluated on the DESMD tear film imaging system.
Data sourced from ClinicalTrials.gov (NCT05554640). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.