N/A
Completed N=36
Performance of Fanfilcon A Toric Lenses After at Least One Month Wearing Enfilcon A Toric Lenses
Astigmatism
Source: ClinicalTrials.gov NCT02921412 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcomePrimary: Visual Acuity — -0.05; -0.05; -0.05; -0.04 logMAR
Summary
This is a prospective, multi-center, subject-masked, bilateral, daily wear, two-month dispensing study
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity |
-0.05; -0.05; -0.05; -0.04 | — |
| PRIMARY Centration |
34; 35; 30; 33; 1; 1 | — |
| PRIMARY Corneal Coverage |
36; 36; 35; 35; 0; 0 | — |
| PRIMARY Post-blink Movement |
1.83; 1.92; 1.69; 1.86 | — |
| PRIMARY Fit Acceptability |
3.3; 3.3; 3.1; 3.1 | — |
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 had a self-reported eye exam in the last two years
- Is a habitual soft toric lens wearer
- Can be successfully fit with study lenses (≥ grade 2 fit acceptance)
- Has a contact lens spherical prescription between -1.00 to -6.00D with a cylinder between -0.75 and -1.75D (Diopters) (inclusive)
- Has a spectacle cylinder of at least 0.75D in each eye.
- Can achieve best corrected spectacle refraction 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
- 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 frequently using rewetting/ lubricating eye drops (more than once per day)
Data sourced from ClinicalTrials.gov (NCT02921412). 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.