Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

Alcon

Status: Completed

Conditions: Myopia

Treatments: Device: Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®); Device: Delefilcon A contact lenses (DAILIES TOTAL1®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01634659

M-12-033

Details and patient eligibility

About

The purpose of this study was to compare the subjective performance of DAILIES TOTAL1® daily disposable contact lenses to that of 1-DAY ACUVUE® TruEye® daily disposable contact lenses.

Enrollment: 330 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sign written Informed Consent Document and HIPAA form.
• Be current weekly/monthly replacement contact lens wearer.
• Be willing to not sleep in contact lenses during the study period.
• Require vision correction in both eyes, with a contact lens prescription in protocol-specified power range.
• Have best corrected visual acuity of at least 20/25 in each eye.
• Be willing to wear study lenses for at least 8 hours/day and at least 5 days/week.
• Use re-wetting drops less than once per day and be willing to discontinue use of rewetting drops while wearing the study contact lenses.
• Other protocol-specified inclusion criteria may apply.

Exclusion criteria

• Be a neophyte or current wearer of daily disposable lenses.
• Require monovision correction or use multifocal contact lenses.
• Have any systemic or ocular disease or disorder, complicating factor, or structural abnormality that would negatively affect the conduct or outcome of the study.
• Have a history of ocular surgery/trauma within the last 6 months.
• Use topical ocular or systemic antibiotics within 7 days of enrollment.
• Use topical ocular or systemic corticosteroids within 14 days of enrollment, continuing throughout the study.
• Have participated in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
• Have habitually worn contact lenses on an extended wear basis (sleeping in habitual contact lenses for at least 2 nights per week) in the last 3 months prior to enrollment.
• Use re-wetting drops once or more per day.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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330 participants in 2 patient groups

Delefilcon A, then narafilcon B

Other group

Description:

Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.

Treatment:

Device: Delefilcon A contact lenses (DAILIES TOTAL1®)

Device: Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)

Narafilcon B, then delefilcon A

Other group

Description:

Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.

Treatment:

Device: Delefilcon A contact lenses (DAILIES TOTAL1®)

Device: Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)