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Clinical Performance of Two Daily Disposable Soft Contact Lenses

Not Applicable
Completed
Conditions
Refractive Errors
Interventions
Device: Verofilcon A contact lenses
Device: Nesofilcon A contact lenses
Registration Number
NCT05138783
Lead Sponsor
Alcon Research
Brief Summary

The purpose of this study is to compare the clinical performance of PRECISION1 contact lenses with Biotrue contact lenses.

Detailed Description

Subjects will be expected to attend 3 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over an 8-day period for each study lens type. The total duration of a subject's participation in the study will be up to 22 days.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
129
Inclusion Criteria
  • Successful wear of spherical soft contact lenses with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
  • Willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.
  • Willing to wear contact lenses for at least 16 hours on the day prior to Visit 2 and the day prior to Visit 3.
  • Other protocol-defined inclusion criteria may apply.

Key

Exclusion Criteria
  • Participation in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
  • Habitual PRECISION1, Biotrue, and DAILIES TOTAL1 contact lens wear.
  • Monovision and multifocal lens wear.
  • Other protocol-defined exclusion criteria may apply.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
PRECISION1, then BiotrueVerofilcon A contact lensesVerofilcon A contact lenses worn first, with nesofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses will be worn each day.
PRECISION1, then BiotrueNesofilcon A contact lensesVerofilcon A contact lenses worn first, with nesofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses will be worn each day.
Biotrue, then PRECISION1Verofilcon A contact lensesNesofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses will be worn each day.
Biotrue, then PRECISION1Nesofilcon A contact lensesNesofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses will be worn each day.
Primary Outcome Measures
NameTimeMethod
Least Squares Mean Distance Visual Acuity (VA) With Study LensesDay 8 (-0/+3 days), each study lens type

Visual Acuity (VA) was collected for each eye individually with study lenses in place using a letter chart. VA was measured in logarithm of the minimum angle of resolution (logMAR). A logMAR value of 0 corresponds to 20/20 Snellen acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (8)

Tallahassee Eye Center

🇺🇸

Tallahassee, Florida, United States

Kindred Optics at Maitland Vision

🇺🇸

Maitland, Florida, United States

Franklin Park Eye Center PC

🇺🇸

Franklin Park, Illinois, United States

Heart of America Eye Care

🇺🇸

Shawnee Mission, Kansas, United States

Complete Eye Care Of Medina

🇺🇸

Medina, Minnesota, United States

ProCare Vision Centers, Inc.

🇺🇸

Granville, Ohio, United States

Clarke EyeCare Center

🇺🇸

Wichita Falls, Texas, United States

Stine Eye Center

🇺🇸

Weston, Wisconsin, United States

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