N/A
N=127
Evaluation of Senofilcon A With New UV-blocker on a Neophyte Population
Visual Acuity
Bottom Line
View on ClinicalTrials.gov: NCT03742271 ↗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
| Outcome | Result | p-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.
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.