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N/A N=14 Randomized Single-blind Treatment

Clinical Performance of Two Daily Disposable Silicone Hydrogel Contact Lenses

Visual Acuity

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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