N/A
Completed N=64
Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses
Source: ClinicalTrials.gov NCT02956460 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcomePrimary: Overall Comfort — 8.4; 8.7 units on a scale
Summary
Prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, 1 month dispensing study (2 weeks each lens pair)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Comfort |
8.4; 8.7 | — |
| PRIMARY Overall Dryness |
8.2; 8.2 | — |
| PRIMARY Vision Quality |
9.0; 8.9 | — |
| PRIMARY Lens Handling |
9.3; 9.4; 8.4; 9.3 | — |
| PRIMARY Vision Satisfaction |
8.7; 8.6 | — |
| PRIMARY Lens Centration |
62; 63; 1; 0; 0; 0 | — |
| PRIMARY Conjunctival Staining |
0.4; 0.6 | — |
| PRIMARY Smoothness |
8.7; 9.1 | — |
| PRIMARY Clean Feeling |
8.7; 8.9 | — |
| PRIMARY Lens Hydrated |
8.3; 8.5 | — |
| PRIMARY Lens Wettability |
8.4; 8.5 | — |
Eligibility Criteria
Inclusion Criteria
A person is eligible for inclusion in the study if he/she:
- Is between 18 and 40 years of age (inclusive)
- Has read, understood and signed the information consent letter
- Has had a self-reported eye exam in the last two years
- Is a spherical soft contact lens wearer
- Has a contact lens prescription that fits within the available parameters of the study lenses
- Has a spectacle cylinder no greater than 0.75D (Diopters) in each eye
- Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye
- Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses
- Has clear corneas and no active ocular disease
- Is willing and anticipated to be able to comply with the wear schedule (8 hours per day; 5 days a week of lens wear)
- Is willing and able to follow instructions and maintain the appointment schedule
Exclusion Criteria
A person will be excluded from the study if he/she:
- Has a history of not achieving comfortable CL (Contact Lens) wear (defined as 5 days per week; >8 hours/day)
- Is currently wearing senofilcon C (2 weeks lens), senofilcon A 1-Day, senofilcon C (monthly lens) or enfilcon A contact lenses
- Is habitually using rewetting/ lubricating eye drops more than once per day
- Presents with clinically significant anterior segment abnormalities
- Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear
- Presents with slit lamp findings that would contraindicate contact lens wear such as:
- Pathological dry eye or associated findings
- Significant pterygium, pinguecula, or corneal scars within the visual axis
- Neovascularization > 0.75 mm in from of the limbus
- Giant papillary conjunctivitis (GCP) worse than grade 1
- Anterior uveitis or iritis (or history in past year)
- Seborrheic eczema of eyelid region, Seborrheic conjunctivitis
- History of corneal ulcers or fungal infections
- Poor personal hygiene
- Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
- Has aphakia, keratoconus or a highly irregular cornea
- Has presbyopia or has dependence on spectacles for near work over the contact lenses
- Has undergone corneal refractive surgery
Data sourced from ClinicalTrials.gov (NCT02956460). 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.