N/A
N=41
Refitting Somofilcon A Sphere Contact Lens Wearers Into Fanfilcon A Sphere Lenses for 4-Weeks of Wear
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT03974802 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Lens Centration for Somofilcon A (Habitual) Lens — 100; 0; 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- somofilcon A contact lens (Device); fanfilcon A contact lens (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lens Centration for Somofilcon A (Habitual) Lens |
100; 0; 0 | — |
| PRIMARY Lens Centration for Somofilcon A (Habitual) Lens |
100; 0; 0 | — |
| PRIMARY Lens Centration for Fanfilcon A (Test) Lens |
100; 0; 0 | — |
| PRIMARY Lens Centration for Fanfilcon A (Test) Lens |
100; 0; 0 | — |
| PRIMARY Lens Centration for Fanfilcon A (Test) Lens |
100; 0; 0 | — |
| PRIMARY Lens Corneal Coverage for Somofilcon A (Habitual) Lens |
100; 0 | — |
| PRIMARY Lens Corneal Coverage for Somofilcon A (Habitual) Lens |
100; 0 | — |
| PRIMARY Lens Corneal Coverage for Fanfilcon A (Test) Lens |
100; 0 | — |
| PRIMARY Lens Corneal Coverage for Fanfilcon A (Test) Lens |
100; 0 | — |
| PRIMARY Lens Corneal Coverage for Fanfilcon A (Test) Lens |
100; 0 | — |
| PRIMARY Percentage of Lens Tightness for Somofilcon A (Habitual) Lens |
51.8 | — |
| PRIMARY Percentage of Lens Tightness for Somofilcon A (Habitual) Lens |
51.8 | — |
| PRIMARY Percentage of Lens Tightness for Fanfilcon A (Test) Lens |
50.2 | — |
| PRIMARY Percentage of Lens Tightness for Fanfilcon A (Test) Lens |
50.2 | — |
| PRIMARY Percentage of Lens Tightness for Fanfilcon A (Test) Lens |
50.2 | — |
| PRIMARY Post-Blink Movement for Somofilcon A (Habitual) Lens |
1.95 | — |
| PRIMARY Post-Blink Movement for Somofilcon A (Habitual) Lens |
1.95 | — |
| PRIMARY Post-Blink Movement for Fanfilcon A (Test) Lens |
2.00 | — |
| PRIMARY Post-Blink Movement for Fanfilcon A (Test) Lens |
2.00 | — |
| PRIMARY Post-Blink Movement for Fanfilcon A (Test) Lens |
2.00 | — |
| PRIMARY Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens |
3.83 | — |
| PRIMARY Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens |
3.83 | — |
| PRIMARY Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens |
3.98 | — |
| PRIMARY Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens |
3.98 | — |
| PRIMARY Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens |
3.98 | — |
| SECONDARY Average Daily Wearing Time - Somofilcon A (Habitual) Lens |
12.1 | — |
| SECONDARY Average Daily Wearing Time - Fanfilcon A (Test) Lens |
12.3 | — |
| SECONDARY Average Daily Wearing Time - Fanfilcon A (Test) Lens |
12.3 | — |
| SECONDARY Average Comfortable Wearing Time - Somofilcon A (Habitual) Lens |
9.8 | — |
| SECONDARY Average Comfortable Wearing Time - Fanfilcon A (Test) Lens |
10.8 | — |
| SECONDARY Average Comfortable Wearing Time - Fanfilcon A (Test) Lens |
10.8 | — |
Summary
The aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses.
Eligibility Criteria
Inclusion Criteria
- Is between 18 and 40 years of age (inclusive)
- Has had a self-reported visual exam in the last two years
- Is an adapted soft contact lens wearer
- Has a contact lens spherical prescription between - 0.25 to - 8.00 (inclusive)
- Have no less than -0.75D of astigmatism in both eyes.
- 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
- Has a CL prescription outside the range of the available parameters of the study lenses.
- Has a spectacle cylinder of ≥ 1.00D 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 2-4) 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 (NCT03974802). 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.