N/A
N=69
Performance Evaluation of Daily Disposable Contact Lenses in Habitual Lens Wearers Who Use Digital Devices Frequently
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT05805150 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Lens Handling on Removal — 90; 95 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Control Lens (stenfilcon A) (Device); Test Lens (senofilcon A) (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lens Handling on Removal |
90; 95 | — |
Summary
The goal of this study is to compare the performance of two daily disposable silicone hydrogel lenses.
Eligibility Criteria
Inclusion Criteria
- Is between 18 and 35 years of age (inclusively) 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;
- Self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone;
- 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;
- No more than 1/3 of participants should be habitual wearer of MyDay or MyDay Energys
- No more than 1/3 of participants should be habitual wearer of ACUVUE® OASYS MAX 1-Day or ACUVUE® OASYS 1-Day.
- 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;
- 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 (NCT05805150). 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.