Clinical Evaluation of ACUVUE® OASYS® 1-Day and ACUVUE® OASYS®

Alcon

Status: Completed

Conditions: Refractive Error

Treatments: Device: Senofilcon A contact lenses with HydraLuxe™; Device: Senofilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT02696317

CLE198-P001

Details and patient eligibility

About

The purpose of this study is to evaluate the performance of two commercially-available silicone hydrogel contact lenses in normal and low humidity environments after at least 7 days of wear.

Full description

After randomization to lens order, subjects attended study visits that included a 3 hour exposure to reduced humidity environment (20% relative humidity) and subsequent tear film assessments for each study lens.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must sign an informed consent form;
• Adapted, current soft silicone hydrogel daily disposable contact lens wearer during the last 2 months;
• Prescription within power range of both study contact lenses, as stated in the protocol;
• Cylinder equal or lower than -0.75 diopter (D) in both eyes;
• Willing to wear lenses every day or at least a minimum of 5 days per week, 6 hours per day;
• Willing to discontinue artificial tears and rewetting drops on the days of study visits;
• Other protocol-specified inclusion criteria may apply.

Exclusion criteria

• Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
• Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
• Monocular (only 1 eye with functional vision) or fit with only 1 lens;
• History of herpetic keratitis, ocular surgery, or irregular cornea;
• Pregnant or lactating;
• Current AO1D or AO lens wearer;
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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84 participants in 2 patient groups

AO1D, then AO

Other group

Description:

Senofilcon A contact lenses with HydraLuxe™, followed by senofilcon A contact lenses. Each product worn bilaterally (in both eyes) for 10 days in a daily wear, daily disposable modality.

Treatment:

Device: Senofilcon A contact lenses

Device: Senofilcon A contact lenses with HydraLuxe™

AO, then AO1D

Other group

Description:

Senofilcon A contact lenses, followed by senofilcon A contact lenses with HydraLuxe™. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.

Treatment:

Device: Senofilcon A contact lenses

Device: Senofilcon A contact lenses with HydraLuxe™