N/A
N=80
Clinical Evaluation of Stenfilcon A Contact Lenses
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT03471832 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Lens Movement — 0; 0; 0; 3 Number of eyes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- stenfilcon A lens (Device); narafilcon A lens (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lens Movement |
0; 0; 5; 11; 32; 26 | — |
| PRIMARY Lens Movement |
0; 0; 5; 11; 32; 26 | — |
| PRIMARY Horizontal Lens Centration |
0; 0; 1; 8; 39; 32 | — |
| PRIMARY Horizontal Lens Centration |
0; 0; 1; 8; 39; 32 | — |
| PRIMARY Vertical Lens Centration |
0; 0; 1; 6; 39; 28 | — |
| PRIMARY Vertical Lens Centration |
0; 0; 1; 6; 39; 28 | — |
| PRIMARY Corneal Coverage |
40; 40; 0; 0 | — |
| PRIMARY Corneal Coverage |
40; 40; 0; 0 | — |
| PRIMARY Lens Lag |
39; 36; 1; 4; 0; 0 | — |
| PRIMARY Lens Lag |
39; 36; 1; 4; 0; 0 | — |
| PRIMARY Overall Fitting Performance |
32; 22; 6; 14; 2; 4 | — |
| PRIMARY Overall Fitting Performance |
32; 22; 6; 14; 2; 4 | — |
| PRIMARY Investigator Fit Preference |
5; 12; 17; 6; 0 | — |
| PRIMARY Investigator Fit Preference |
5; 12; 17; 6; 0 | — |
| SECONDARY Comfort |
8.2; 8.4 | — |
| SECONDARY Comfort |
8.2; 8.4 | — |
| SECONDARY Comfort |
8.2; 8.4 | — |
| SECONDARY Dryness |
8.5; 8.4 | — |
| SECONDARY Dryness |
8.5; 8.4 | — |
| SECONDARY Dryness |
8.5; 8.4 | — |
| SECONDARY Stinging/Burning |
9.6; 9.6 | — |
| SECONDARY Stinging/Burning |
9.6; 9.6 | — |
| SECONDARY Stinging/Burning |
9.6; 9.6 | — |
| SECONDARY Edge/Lens Awareness |
8.7; 9.2 | — |
| SECONDARY Edge/Lens Awareness |
8.7; 9.2 | — |
| SECONDARY Edge/Lens Awareness |
8.7; 9.2 | — |
| SECONDARY Subjective Lens Preference |
12; 18; 1; 9 | — |
| SECONDARY Subjective Lens Preference |
12; 18; 1; 9 | — |
| SECONDARY Subjective Lens Preference |
12; 18; 1; 9 | — |
Summary
This study is to evaluate the fitting performance of stenfilcon A contact lens (test) compared to narafilcon A contact lens (control).
Eligibility Criteria
Inclusion Criteria
A person is eligible for inclusion in the study if he/she:
- Is Japanese
- Has had a self-reported oculo-visual examination in the last two years.
- Is at least 18 years of age and has full legal capacity to volunteer.
- Has read and understood the informed consent letter.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
- Currently wears soft contact lenses.
- Has clear corneas and no active ocular disease.
Exclusion Criteria
A person will be excluded from the study if he/she:
- Has never worn contact lenses before.
- Has any systemic disease affecting ocular health.
- Is using any systemic or topical medications that will affect ocular health.
- Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
- Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
- Is aphakic.
- Has undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
Data sourced from ClinicalTrials.gov (NCT03471832). 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.