Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear

Alcon

Status: Completed

Conditions: Refractive Error

Treatments: Device: FID122819 contact lenses; Device: Stenfilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT03095027

CLE383-C003

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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54 participants in 2 patient groups

FID122819, then stenfilcon A

Other group

Description:

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

Treatment:

Device: Stenfilcon A contact lenses

Device: FID122819 contact lenses

Stenfilcon A, then FID122819

Other group

Description:

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

Treatment:

Device: Stenfilcon A contact lenses

Device: FID122819 contact lenses