Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear

Not Applicable

Completed

Interventions: Device: FID122819 contact lenses
Device: Stenfilcon A contact lenses

Brief Summary: The purpose of this study is to compare the visual acuity of an investigational silicone hydrogel to a commercially available silicone hydrogel in contact lens wearers.

Recruitment & Eligibility

Inclusion Criteria

Able to understand and sign an IRB-approved Informed Consent Form;
Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months:
Manifest cylinder of ≤ 0.75 diopter (D) in each eye;
Best corrected visual acuity (BCVA) of 20/25 or better in each eye;
Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

Any anterior segment infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator;
Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
History of refractive surgery or plan to have refractive surgery during the study;
Ocular or intraocular surgery within the previous 12 months or planned during the study;
Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
Any previous or current wear of MYDAY;
Habitually wearing monovision or multifocal lenses during the last 3 months;
Routinely sleeping in lenses for at least 1 night per week over the last 3 months prior to enrollment;
Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
Other protocol-defined exclusion criteria may apply.

Arm && Interventions

Group	Intervention	Description
FID122819, then stenfilcon A	FID122819 contact lenses	FID122819 contact lenses worn first, followed by stenfilcon A contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week
Stenfilcon A, then FID122819	FID122819 contact lenses	Stenfilcon A contact lenses worn first, followed by FID122819 contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week
FID122819, then stenfilcon A	Stenfilcon A contact lenses	FID122819 contact lenses worn first, followed by stenfilcon A contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week
Stenfilcon A, then FID122819	Stenfilcon A contact lenses	Stenfilcon A contact lenses worn first, followed by FID122819 contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week

Primary Outcome Measures

Name	Time	Method
Visual Acuity (VA)	Baseline/Dispense (Day 1), Week 1, each product	VA was assessed and collected using a Snellen chart. Conversion to logMAR (logarithm of the minimum angle of resolution) was performed. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity. Both eyes contributed to the analysis.

Secondary Outcome Measures