Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

Alcon

Status: Completed

Conditions: Myopia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01561560

P-347-C-019

Details and patient eligibility

About

The purpose of this crossover study was to evaluate the end-of-day comfort of two commercially available, daily disposable, silicone hydrogel contact lenses.

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sign written Informed Consent Document.
• Currently wearing soft contact lenses in both eyes and identified as symptomatic based on questionnaire responses.
• Currently wearing either daily disposable contact lenses or weekly/monthly replacement contact lenses.
• Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses in the available parameters.
• Willing to wear study lenses for at least eight hours per day and at least five days per week.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Has not worn contact lenses before.
• Currently wearing DAILIES TOTAL1 or 1-DAY ACUVUE TRUEYE contact lenses.
• Any systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study.
• Ocular surgery/trauma within the last six months.
• Topical ocular or systemic use of antibiotics within seven days of enrollment.
• Pregnant or nursing women.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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123 participants in 2 patient groups

DAILIES TOTAL1, then TRUEYE

Other group

Description:

Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.

Treatment:

Device: Delefilcon A contact lenses

Device: Narafilcon A contact lenses

TRUEYE, then DAILIES TOTAL1

Other group

Description:

Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.

Treatment:

Device: Delefilcon A contact lenses

Device: Narafilcon A contact lenses