N/A
N=548
Clinical Study of Approved and Investigational Contact Lenses
Visual Acuity
Bottom Line
View on ClinicalTrials.gov: NCT02708524 ↗Enrolled (actual)
548
Serious AEs
0.2%
Results posted
Nov 2016
Primary outcome: Primary: Subjective Overall Comfort Composite Score — 65.17; 68.58; 66.45; 65.46 average clue score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Senofilcon C Contact Lens (Device); Comfilcon A Contact Lens (Device); Lotrafilcon B Contact Lens (Device); Samfilcon A Contact Lens (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Overall Comfort Composite Score |
65.17; 68.58; 66.45; 65.46; 66.65; 62.11 | — |
| PRIMARY Overall Comfort Individual Item |
78; 82; 80; 77; 79.1; 50.7 | — |
| PRIMARY Comfort at the End of the Day Individual Item |
57.5; 64.6; 60.9; 64.0; 64.2; 47.0 | — |
| PRIMARY Comfort Each and Everyday Individual Item |
73.2; 76.1; 78.3; 76.5; 79.1; 59.2 | — |
| PRIMARY Frequency of Lens Awareness Individual Item |
73.2; 74.5; 77.4; 75.8; 75.4; 61.6 | — |
| PRIMARY Frequency of Experiencing Dryness Individual Item |
62.7; 67.7; 71.4; 67.6; 67.9; 62.5 | — |
| PRIMARY Making Your Eyes Feel Moist Throughout the Day Individual Item |
68.6; 52.3; 43.7; 55.2; 58.6; 52.3 | — |
| SECONDARY Subjective Overall Quality of Vision Composite Score |
63.79; 63.31; 64.12; 62.34; 69.45; 68.96 | — |
| SECONDARY Overall Quality of Vision Individual Item |
82.9; 86.9; 91.0; 84.5; 89.5; 77.7 | — |
| SECONDARY Overall Opinion Individual Item |
85.8; 73.8; 60.9; 80.9; 75.4; 49.3 | — |
Summary
This is a multi-site, 5-visit, double-masked, dispensing study comparing an investigational contact lens with currently-marketed contact lenses. The objective of the study is to evaluate the comfort of the lenses when worn for 30 (-2/+6) days on daily wear modality.
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.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- The subject must be between 18 to 40 years of age at the time of consent.
- The subject's spherical equivalent distance refraction must be in the range of -1.25 to -6.00 in each eye.
- The subject's refractive cylinder must be ≤1.00D in each eye.
- The subject must have best corrected visual acuity of 20/30 or better in each eye.
- The subject must be a habitual frequent replacement (reusable) daily wear spherical silicone hydrogel soft contact lens wearer in both eyes.
- The subject must be able to wear contact lenses for a minimum of 8 hours, 4 days per week.
- The subject must have normal eyes (i.e., no ocular medications or infections of any type).
Exclusion Criteria
- Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
- Any known sensitive/allergic to Ingredients of OPTI-FREE® PureMoist® solution.
- Any daily disposable, extended wear, monovision, toric or multi-focal contact lens correction.
- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.
- Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
- 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.
- Any ocular infection.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- 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).
- Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
Data sourced from ClinicalTrials.gov (NCT02708524). 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.