N/A
Completed N=35
Clinical Performance of Existing Wearers of Enfilcon A Following a Refit With Fanfilcon A Lenses for 4 Weeks
Source: ClinicalTrials.gov NCT02670473 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Lens Fit - Centration — 88; 97; 99; 100 percentage of eyes
Summary
The aim of this dispensing study is to evaluate the clinical performance of habitual wearers of enfilcon A lenses following a refit with fanfilcon A lenses over 4 weeks of daily wear.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lens Fit - Centration |
88; 97; 99; 100; 12; 3 | — |
| PRIMARY Lens Fit - Post-blink Movement |
0; 0; 0; 0; 1; 1 | — |
| PRIMARY Lens Tightness on Push-up |
50; 49; 50; 50 | — |
| PRIMARY Overall Fit Acceptance |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Overall Comfort |
8.03; 8.91; 8.97; 8.85 | — |
| SECONDARY Dryness Overall |
7.88; 8.82; 8.85; 8.82 | — |
| SECONDARY Handling |
8.85; 9.26; 9.59; 9.62 | — |
| SECONDARY Overall Vision Satisfaction |
9.24; 9.56; 9.79; 9.74 | — |
| SECONDARY Overall Satisfaction |
26; 71; 3; 0; 53; 47 | — |
| SECONDARY Lens Preference Overall |
18; 82; 6; 94; 6; 94 | — |
| SECONDARY Wearing Times |
8.79; 9.82; 9.65; 9.85; 7.65; 8.97 | — |
| SECONDARY Conjunctival Staining |
100; 97; 99; 94; 0; 3 | — |
| SECONDARY Corneal Staining |
100; 100; 100; 100; 0; 0 | — |
Eligibility Criteria
Inclusion criteria
A person is eligible for inclusion in the study if he/she:
- Is between 18 and 40 years of age
- Has had a self-reported visual exam in the last two years
- Is an adapted enfilcon A contact lens wearer (at least 2 weeks in enfilcon A lens)
- Has a contact lens spherical prescription between -1.00 to - 6.00
- Has a spectacle cylinder up to 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.
- Patient contact lens refraction should fit 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:
- Is not a habitual wearer of enfilcon A lenses
- Has a CL (Contact Lens) prescription outside the range of the available parameters of the study lenses.
- Has a spectacle cylinder ≥1.00D of cylinder in either eye.
- Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
- Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
- Presence of clinically significant (grade 3-4) anterior segment abnormalities
- Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
- Slit lamp findings that would contraindicate contact lens wear such as:
- Pathological dry eye or associated findings
- 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 (past or present)
- Seborrheic eczema, 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.
Data sourced from ClinicalTrials.gov (NCT02670473). 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.