Clinical Evaluation of MyDay™ and 1-DAY ACUVUE® TruEye®

Alcon

Status: Completed

Conditions: Refractive Error

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02388763

CLY838-P001

Details and patient eligibility

About

The purpose of this study is to evaluate the functional vision of 2 daily disposable silicone hydrogel contact lenses using Time Controlled Visual Acuity (TCVA) measurements at high luminance and high contrast after 10+/-3 days of wear post 3 hour exposure to a reduced humidity environment.

Full description

After randomization, participants attended a baseline visit to include a 3 hour exposure to reduced humidity environment. The participant's habitual lenses were worn for the baseline visit.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must sign informed consent form.
• Adapted, current soft silicone hydrogel daily disposable contact lens wearer during the last 2 months.
• Willing to wear lenses every day or at least 5 days per week 6 hours per day.
• Willing to discontinue artificial tears and rewetting drops usage on the days of study visits.
• Other protocol-specified inclusion criteria may apply.

Exclusion criteria

• Monocular (only 1 eye with functional vision) or fit with only 1 lens.
• Pregnant or lactating.
• Current MyDay™ or 1DAY ACUVUE® TruEye® lens wearer.
• Any abnormal ocular condition as specified in the protocol.
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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66 participants in 2 patient groups

MyDay, then 1DAVTE

Other group

Description:

Stenfilcon A contact lenses, followed by narafilcon A contact lenses. Each product worn bilaterally (in both eyes) for 10 days in a daily wear, daily disposable modality.

Treatment:

Device: Narafilcon A contact lenses

Device: Stenfilcon A contact lenses

1DAVTE, then MyDay

Other group

Description:

Narafilcon A contact lenses, followed by stenfilcon A contact lenses. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.

Treatment:

Device: Narafilcon A contact lenses

Device: Stenfilcon A contact lenses