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Clinical Trials/NCT05138783
NCT05138783
Completed
Not Applicable

Clinical Performance of Two Daily Disposable Soft Contact Lenses

Alcon Research8 sites in 1 country129 target enrollmentJanuary 12, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Refractive Errors
Sponsor
Alcon Research
Enrollment
129
Locations
8
Primary Endpoint
Least Squares Mean Distance Visual Acuity (VA) With Study Lenses
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 12, 2022
End Date
March 7, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • Other protocol-defined inclusion criteria may apply.

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.

Outcomes

Primary Outcomes

Least Squares Mean Distance Visual Acuity (VA) With Study Lenses

Time Frame: Day 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.

Study Sites (8)

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