N/A
Completed N=87
Performance Comparison Between Comfilcon A and Senofilcon C Lenses
Source: ClinicalTrials.gov NCT02920957 ↗Enrolled (actual)
87
Serious AEs
0.6%
Results posted
Jan 2018
Primary outcomePrimary: Overall Lens Fit Acceptance — 3.6; 3.5; 3.5; 3.5 units on a scale
Summary
The aim of this study is to determine the clinical performance of comfilcon A in comparison to senofilcon C.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Lens Fit Acceptance |
3.6; 3.5; 3.5; 3.5; 3.5; 3.3 | — |
| PRIMARY Corneal Coverage |
85; 84; 82; 83; 82; 83 | — |
| PRIMARY Lens Centration |
77; 78; 76; 71; 71; 76 | — |
| PRIMARY Post-blink Movement |
1.8; 1.9; 1.9; 1.9; 1.9; 1.8 | — |
| PRIMARY Lens Lag at Primary Gaze |
0.2; 0.2; 0.2; 0.2; 0.2; 0.2 | — |
| PRIMARY Tightness on Push up |
54; 51; 51; 54; 53; 53 | — |
| PRIMARY Lens Wettability |
3.8; 3.5; 3.4; 3.7; 3.3; 3.3 | — |
| PRIMARY Deposit Grading |
0.0; 0.3; 0.5; 0.1; 0.4; 0.7 | — |
Eligibility Criteria
Inclusion Criteria
A person is eligible for inclusion in the study if he/she:
- Is between 18 and 34 years of age (inclusive)
- Has had a self-reported eye exam in the last two years
- Is a spherical soft contact lens wearer
- Has a contact lens spherical prescription between -1.00 to -6.00 (inclusive)
- 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
- Has read, understood and signed the information consent letter.
- Has a contact lens prescription that fits within the available parameters of the study lenses.
- Is willing and anticipated to be able to comply with the wear schedule (at least 6 days per week, 12 hours/day assuming there are no contraindications for doing so).
- Is willing to comply with the visit 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 6 days per week; > 10 hours/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.
- Is participating in any other type of eye related clinical or research study.
- Is habitually using rewetting/ lubricating eye drops more than once per day
- Is currently wearing daily disposable lenses
Data sourced from ClinicalTrials.gov (NCT02920957). 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.