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N/A N=127 Treatment

Evaluation of Senofilcon A With New UV-blocker on a Neophyte Population

Visual Acuity

Enrolled (actual)
127
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Acceptable Lens Fitting — 0.974 Proportion of subjects

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
senofilcon A (Device)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Johnson & Johnson Vision Care, Inc.
Primary completion
Mar 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Acceptable Lens Fitting
0.974

Summary

This is a 5-visit, single-arm, open-label, dispensing study. Each subject will be bilaterally fit with the test article for approximately 4 weeks of reusable daily wear with lens replacement occurring 2-weeks after initial dispensing. After 4 weeks of study lens wear, subjects will return to their habitual spectacles for one week.

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 39 (inclusive) years of age at the time of screening.
  • They are a contact lens 'neophyte'. In this work 'neophyte' is taken to mean any subject who has never been dispensed contact lenses. A subject who had taken part in a non-dispensing clinical study or had been fitted with contact lenses in practice but never went on to actually wear the lenses, is also classified as a 'neophyte'.
  • Habitual spectacles must have resulted from an eye exam within the past six months.
  • The subject must have worn the updated spectacles for at least two weeks.
  • Be a current wearer of prescription spectacles that provide corrected monocular visual acuity of 20/25 or better in each eye.
  • The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 D (inclusive) in each eye.
  • The subject's refractive cylinder must be -1.00 D or less in each eye.
  • Have spherocylindrical best corrected distance Snellen visual acuity of 20/25 or better in each eye.

Exclusion Criteria

  • Potential subjects who meet any of the following criteria will be excluded from participating
  • Currently pregnant or lactating.
  • Any active or ongoing 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.
  • Use of systemic medications that have a high likelihood to interfere with contact lens wear (estrogens, antihistamines, anticholinergics, beta-blockers, and psychotropics).
  • Any current use of ocular medication.
  • Any known hypersensitivity or allergic reaction to any ingredient in Opti-Free PureMoist.
  • Any previous or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
  • 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 4 slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA slit lamp classification scale.
  • Binocular vision abnormality or strabismus.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03742271). 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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