Refractive Error - Myopia Bilateral
Conditions
Brief summary
The study will compare the short-term clinical performance and wearer and practitioner acceptability of a new-to-market spherical daily disposable (DD) hydrogel soft contact lens to a currently marketed spherical DD hydrogel soft contact lens.
Detailed description
This randomized clinical trial will compare the short-term clinical performance, and wearer acceptability of a new-to-market hioxifilcon A spherical daily DD contact lenses against marketed DD lenses in a short cross-over clinical trial. The primary outcome variable for this study is overall subjective comfort.
Interventions
Daily disposable contact lens wear for 1 week
Sponsors
Vision Service Plan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Clinician masking achieved by clinic coordinator dispensing lenses. Open label to participants.
Intervention model description
Randomized cross-over with 1 week of lens wear with each contact lens type.
Eligibility
Sex/Gender
ALL
Age
18 Years to 42 Years
Healthy volunteers
Yes
Inclusion criteria
* Currently wearing hydrogel, spherical DD contact lenses at least 5 days/week * Vision correctable to 20/30 acuity in each eye with spherical DD contact lenses * No ocular or systemic disease that contra-indicates soft contact lens wear
Exclusion criteria
* Currently wearing silicone hydrogel DD contact lenses * Currently wearing 1-DAY ACUVUE® MOIST (comparator) contact lenses * Currently using rewetting drops with habitual contact lenses * Vision not correctable to 20/30 * Participating in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall subjective comfort | 1 week after contact lens wear | Subjective comfort rating on a scale of 0 (Painful) to 10 (Can't feel the lenses) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| End of day subjective comfort | Visit 2 and 3 - Approximately 1 and 2 weeks, respectively | Subjective comfort rating on a scale of 0 (Painful) to 10 (Can't feel the lenses) |
| Subjective vision | Visit 2 and 3 - Approximately 1 and 2 weeks, respectively | Subjective vision rating on a scale of 0 (Not at all sharp/clear) to 10 (Sharp/Clear) |
| Overall subjective lens preference | Visit 3 - After approximately 2 weeks of contact lens wear | Forced choice subjective preference for either lens type (1-Day ACUVUE® MOIST or Test DD contact lens) or no preference. i.e. three options presented and participant selects one option. |
Countries
United States
Outcome results
None listed