Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

Alcon Research123 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

123

Conditions

Myopia

Interventions

Delefilcon A contact lensesDEVICE

CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two

Narafilcon A contact lensesDEVICE

CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

End-of-day Comfort

End-of-day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective measurement of two weeks of wear. Participants were asked, "Please rate the study lenses you have been wearing the in the following area: End-of-day comfort" and recorded their response on a continuous 1-10 Likert scale (1=poor and 10=excellent).

Time frame: Week 2

Data from ClinicalTrials.gov

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