N/A
Completed N=54
One Month Dispensing Study Comparing the Clinical Performance of the Comfilcon A Sphere Lenses Compared to Comfilcon A Asphere Lenses.
Source: ClinicalTrials.gov NCT02759471 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcomePrimary: Lens Fit - Centration — 48; 46; 4; 6 participants
Summary
This is a prospective, multi-center, subject-masked, bilateral wear, one month dispensing study comparing the clinical performance of the subjects' habitual comfilcon A sphere lens (control) following a refit with comfilcon A asphere lens (test). After the dispensing visit, subjects will return for follow-up evaluations after 2 weeks, and 1 month.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lens Fit - Centration |
48; 46; 4; 6; 0; 0 | — |
| PRIMARY Lens Fit - Corneal Coverage |
52; 52; 51; 51; 51; 51 | — |
| PRIMARY Lens Fit - Post-blink Movement |
1.9; 1.9; NA; 1.9; NA; 1.9 | — |
| PRIMARY Lens Preference/Acceptability |
5; 39; 8; 0 | — |
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 an adapted comfilcon A sphere contact lens wearer
- Uses digital devices, (e.g. computer, tablet, smart phone, iPad), for more than 4 hours a day, 5 days a week.
- 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 refraction that fits within the available parameters of the study lenses.
- Is willing to comply with the wear schedule (at least 5 days per week, > 8 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 (5 days per week; > 8 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)
Data sourced from ClinicalTrials.gov (NCT02759471). 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.