Clinical Performance of Two Daily Disposable Soft Contact Lenses

Not Applicable

Completed

• Conditions: Refractive Errors

• 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.

Study Timeline

• Study First Submitted: 2021-11-15
• Study First Submitted QC: 2021-11-15
• Study First Posted: 2021-12-01
• Study Start: 2022-01-12
• Primary Completion: 2022-03-07
• Study Completion: 2022-03-07
• Status Verified: 2023-03
• Results First Submitted: 2023-03-06
• Results First Submitted QC: 2023-03-29
• Last Update Submitted: 2023-03-29
• Results First Posted: 2023-04-18
• Last Update Posted: 2023-04-18

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

Primary Outcome Measures

Name	Time	Method
Least Squares Mean Distance Visual Acuity (VA) With Study Lenses	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.

Trial Locations

Locations (8)

Kindred Optics at Maitland Vision; 🇺🇸 Maitland, Florida, United States

Tallahassee Eye Center; 🇺🇸 Tallahassee, 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