A Prospective Study of Two Daily Disposable Contact Lenses

Alcon

Status: Completed

Conditions: Myopia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01636986

A00930

Details and patient eligibility

About

The purpose of this study was to evaluate the performance of a novel silicone hydrogel contact lens, DAILIES TOTAL1® (DT1) compared to the standard hydrogel material in 1-DAY ACUVUE® MOIST® (1DAVM) contact lens in contact lens wearers identified as having contact lens-related dryness symptoms.

Full description

Three study visits occurred over the course of 28 ± 3 days.

Enrollment: 62 patients

Sex: All

Ages: 18 to 43 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be of legal age of consent and sign written Informed Consent Document and HIPAA form.
• Currently wearing soft contact lenses and identified as having contact lens-related dryness symptoms based upon responses to the Contact Lens Dry Eye Questionnaire.
• Wearing either daily disposable contact lenses or bi-weekly/monthly replacement contact lenses, daily wear use only (no extended wear use).
• Able to achieve distance visual acuity of at least 20/25 in each eye with study lenses in the available parameters, -0.50D to -6.00D.
• Willing to wear study lenses for at least 8 hours/day and at least 5 days/week.
• Willing and able to follow instructions and maintain the appointment schedule.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Neophyte or current wearer of DAILIES TOTAL1® or 1-DAY ACUVUE® MOIST™ contact lenses.
• Requires monovision or presbyopic correction.
• Any systemic or ocular disease or disorder complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
• Recent (within 7 days of enrollment) or current ocular infection, active ocular inflammation, glaucoma or preauricular lymphadenopathy.
• Clinically significant lash or lid abnormality.
• Systemic disease that, in the investigator's best judgment, would prohibit or confound safe contact lens wear.
• History of ocular surgery/trauma within the last 6 months.
• Topical or systemic antibiotics use within 7 days of enrollment.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

DT1

Experimental group

Description:

Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks

Treatment:

Device: Delefilcon A contact lenses

1DAVM

Active Comparator group

Description:

Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks

Treatment:

Device: Etafilcon A contact lenses