N/A
N=295
Validation of Senofilcon A With New UV / HEV Filter
Visual Acuity
Bottom Line
View on ClinicalTrials.gov: NCT05099380 ↗Enrolled (actual)
295
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Overall Quality of Vision Score — 67.0; 70.4 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- senofilcon A C3 (Device); senofilcon A (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Quality of Vision Score |
67.0; 70.4 | — |
| PRIMARY Distance Monocular logMAR Visual Acuity |
-0.12; -0.11 | — |
| PRIMARY Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings |
0; 0 | — |
| PRIMARY Proportion of Eyes With Unacceptable Lens Fitting |
0; 0 | — |
| SECONDARY Overall Comfort Scores |
70.5; 70.4 | — |
| SECONDARY Overall Handling Scores |
69.2; 67.8 | — |
| SECONDARY Situational Visual Performance - Indoors |
0; 0; 75; 85; 51; 48 | — |
| SECONDARY Situational Visual Performance - Digital Devices |
17; 12; 16; 16; 61; 48 | — |
Summary
This is a bilateral, dispensing, randomized, controlled, subject-masked, 2-arm parallel study to evaluate safety and efficacy
Eligibility Criteria
Inclusion Criteria
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- 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.
- Be between 18 and 39 (inclusive) years of age at the time of screening.
- By self-report, habitually wear spherical silicone hydrogel soft contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days.
- Have a habitual contact lens prescription that is current within the prior 6 months, and they must have worn that prescription for at least 2 weeks prior to entering the study.
- The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 through -6.00 D in both eyes.
- The subject's refractive cylinder must be 1.00 D or less.
- The subject must have best corrected 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 in the study:
- Be currently pregnant or lactating.
- Have any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- Have any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable.
- Have any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
- Be currently wearing lenses in a monovision, multifocal, toric, or extended wear modality.
- Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment
- Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
- Have a history of binocular vision abnormality or strabismus.
- Have any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report. 10. Have any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
- Have any ocular infection. 12. Have any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- Have entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
Data sourced from ClinicalTrials.gov (NCT05099380). 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.