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N/A Completed N=135 Randomized Double-blind Treatment

Clinical Evaluation of Senofilcon A Contact Lenses Using a Novel Manufacturing Technology

Visual Acuity
Source: ClinicalTrials.gov NCT04531241 ↗
Enrolled (actual)
135
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcomePrimary: Overall CLUE Comfort — 60.9; 65.1 unit on a scale

Summary

This study is a multi-site, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and Control lenses in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods.

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall CLUE Comfort
60.9; 65.1
PRIMARY
Overall CLUE Vision
65.5; 67.8
SECONDARY
Visual Performance
0.02; 0.03; 0.02; 0.03
SECONDARY
Average Daily Wear Time (in Hours)
14.3; 14.4

Eligibility Criteria

Inclusion Criteria

  • 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.
  • Must be at least 18 and not more than 70 years of age (including 70) at the time of screening.
  • The subject must be a habitual and adapted wearer of daily disposable contact lenses in both eyes (at least 1 month of daily wear).
  • The subject must have normal eyes (i.e., no ocular medications or infections of any type).
  • The subject's required spherical contact lens prescription must be in the range of -0.50 to -3.25 and -3.75 to -6.00 D in each eye.
  • The subject's refractive cylinder must be ≤0.75D in each eye, if present
  • The subject must have best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria

  • Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
  • Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear. (at the discretion of the investigator)
  • Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
  • Any ocular infection.
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  • Monovision or multi-focal contact lens correction.
  • Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
  • History of binocular vision abnormality or strabismus.
  • Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).
  • Suspicion of or recent history of alcohol or substance abuse.
  • History of serious mental illness.
  • History of seizures.
  • Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)
  • Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion
  • Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Food and Drug Administration (FDA) classification scale.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04531241). 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. Informational only — not medical advice.

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