Clinical Performance Assessment of Two Silicone Hydrogel Daily Disposable Contact Lenses

Not Applicable

Completed

• Conditions: Refractive Errors; Myopia

• Registration Number: NCT05725317
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to assess the overall clinical performance of a contact lens made with a modified manufacturing process.

Detailed Description

The expected duration of subject participation in the study is approximately 4 days with 2 scheduled visits.

Study Timeline

• Study First Submitted: 2023-02-03
• Study First Submitted QC: 2023-02-03
• Study First Posted: 2023-02-13
• Study Start: 2023-06-02
• Primary Completion: 2023-06-27
• Study Completion: 2023-06-27
• Disposition First Submitted: 2024-06-19
• Results First Submitted: 2024-06-24
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-15
• Last Update Submitted: 2024-07-15
• Results First Posted: 2024-08-06
• Disposition First Posted: 2024-08-06
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• Successful wearer of spherical soft contact lenses of the same brand in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
• Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
• Best corrected visual acuity (BCVA) better than or equal to 0.10 logMAR in each eye.
• Other protocol-specified inclusion criteria may apply.

Key

Exclusion Criteria

• Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during study participation.
• Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
• Habitual monovision or multifocal contact lens wearers.
• Other protocol-specified exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Least Squares Mean Distance Visual Acuity (VA) With Study Lenses at Day 4	Day 4	VA was assessed for each eye individually at a distance of 4 meters with contact lenses in place using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.

Trial Locations

Locations (7)

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

Vision Health Institute; 🇺🇸 Orlando, Florida, United States

Franklin Park Eye Center PC; 🇺🇸 Franklin Park, Illinois, United States

SUNY College of Optometry Clinical Vision Research Center; 🇺🇸 New York, New York, United States

Wyomissing Optometric Center; 🇺🇸 Wyomissing, Pennsylvania, United States

Optometry Group, PLLC; 🇺🇸 Memphis, Tennessee, United States

Clarke Eyecare Center; 🇺🇸 Wichita Falls, Texas, United States