N/A
N=66
Evaluation of the Performance of Different Daily Disposable Lens Designs in Habitual Soft Contact Lens Wearers
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT04668989 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Lens Wettability — 3.7; 3.7 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- stenfilcon A - (Test lens) (Device); kalifilcon A - (Control Lens) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lens Wettability |
3.5; 3.5 | — |
| PRIMARY Lens Wettability |
3.5; 3.5 | — |
Summary
The main objective of the study is to refit existing soft lens wearers with two different daily disposable contact lens types, Lens A and Lens B, to determine their performance after one week of wear.
Eligibility Criteria
Inclusion Criteria
- Is at least 18 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Self reports having a full eye examination in the previous two years;
- Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Habitually wears soft contact lenses, for the past 3 months minimum;
- Has refractive astigmatism no higher than -0.75DC in each eye;
- Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere -1.00 to -6.00D, 0.25D steps).
Exclusion Criteria
- Is participating in any concurrent clinical or research study;
- Habitually wears one of the study contact lenses;
- Has any known active* ocular disease and/or infection that contraindicates contact lens wear;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
- Has known sensitivity to the diagnostic sodium fluorescein used in the study;
- Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
- Has undergone refractive error surgery or intraocular surgery.
Data sourced from ClinicalTrials.gov (NCT04668989). 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.