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Clinical Performance of Two Daily Disposable Toric Soft Contact Lenses

Not Applicable
Completed
Conditions
Refractive Errors
Astigmatism
Ametropia
Interventions
Device: Verofilcon A toric contact lenses
Device: Etafilcon A toric contact lenses
Registration Number
NCT04908488
Lead Sponsor
Alcon Research
Brief Summary

The purpose of this study is to compare the clinical performance of PRECISION1™ for Astigmatism (P1fA) contact lenses with 1-DAY ACUVUE MOIST® for ASTIGMATISM (AMfA) contact lenses.

Detailed Description

Subjects will be expected to attend 4 visits and wear study lenses daily for at least 10 hours per day. The total duration of subject participation will be up to 22 days.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
115
Inclusion Criteria
  • Successful wear of toric soft contact lenses in both eyes for a a minimum of 5 days per week and 10 hours per day during the past 3 months.
  • Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
  • Habitual PRECISION1 for Astigmatism or 1-DAY ACUVUE MOIST for ASTIGMATISM contact lens wearers.
  • Any spherical monovision and multifocal lens wearers.
  • Routinely sleeping in contact lenses for at least 1 night per week over the last 3 months prior to enrollment.
  • Other protocol-defined exclusion criteria may apply.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
P1fA, then AMfAVerofilcon A toric contact lensesVerofilcon A toric contact lenses worn first, with etafilcon A toric contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
P1fA, then AMfAEtafilcon A toric contact lensesVerofilcon A toric contact lenses worn first, with etafilcon A toric contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
AMfA, then P1fAVerofilcon A toric contact lensesEtafilcon A toric contact lenses worn first, with verofilcon A toric contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
AMfA, then P1fAEtafilcon A toric contact lensesEtafilcon A toric contact lenses worn first, with verofilcon A toric contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
Primary Outcome Measures
NameTimeMethod
Least Squares Mean Distance VA (logMAR) With Study LensesDay 8 (-0/+3 days), each study lens type

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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (8)

Alcon Investigator 8135

🇺🇸

Los Angeles, California, United States

Alcon Investigator 8062

🇺🇸

Oakland, California, United States

Alcon Investigator 6355

🇺🇸

Orlando, Florida, United States

Alcon Investigator 6614

🇺🇸

Franklin Park, Illinois, United States

Alcon Investigator 3382

🇺🇸

Wyomissing, Pennsylvania, United States

Alcon Investigator 6353

🇺🇸

Memphis, Tennessee, United States

Alcon Investigator 6645

🇺🇸

Shawnee Mission, Kansas, United States

Alcon Investigator 2786

🇺🇸

Memphis, Tennessee, United States

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