Clinical Performance of Two Commercial, Daily Disposable Contact Lenses

Alcon Research112 enrolled

Overview

The purpose of this study is to compare the clinical performance of DAILIES TOTAL1 ( DT1) contact lenses with Infuse contact lenses.

Subjects will wear two products and be expected to attend 3 office visits. The individual duration of participation will be approximately 3 weeks, which includes 16 to 22 days of lens wear.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

112

Conditions

Refractive Errors Ametropia Myopia

Interventions

Delefilcon A contact lensesDEVICE

Commercially available silicone hydrogel contact lenses used as indicated

Kalifilcon A contact lensesDEVICE

Commercially available silicone hydrogel contact lenses used as indicated

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Habitually wears soft contact lenses in both eyes at least 5 days per week and at least 10 hours per day; * At least 3 months of contact lens wearing experience; * Less than or equal to 0.75 diopter (D) astigmatism in each eye; * Best Corrected Visual Acuity (BCVA) better than or equal to 20/25 in each eye. * Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: * Current/previous DAILIES TOTAL1 and/or Infuse habitual lens wearer; * Monovision and/or multifocal lens wearer; * Routinely sleeps in habitual contact lenses. * Other protocol-defined exclusion criteria may apply.

Locations (8)

Alcon Investigator 6355

Orlando, Florida, United States

Alcon Investigator 6418

Tallahassee, Florida, United States

Alcon Investigator 3950

Bloomington, Illinois, United States

Alcon Investigator 6614

Franklin Park, Illinois, United States

Outcomes

Primary Outcomes

Least Squares Mean Distance VA (logMAR) With Study Lenses

Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.

Time frame: Day 8 (-0/+3), each study lens type

Data from ClinicalTrials.gov

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