Clinical Comparison of Two Daily Disposable Contact Lenses

Not Applicable

Completed

• Conditions: Refractive Errors
• Interventions: Device: Verofilcon A contact lenses; Device: Somofilcon A contact lenses

• Registration Number: NCT04865354
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to compare the clinical performance of PRECISION1™ contact lenses to Clariti® 1 day contact lenses.

Detailed Description

Subjects will be expected to attend 3 study visits and wear the study lenses daily for at least 10 hours per day. On the day prior to Visits 2 and 3, subjects will be expected to wear the study lenses for at least 16 hours. The total duration of subject participation will be up to 22 days.

Study Timeline

• Study First Submitted: 2021-04-26
• Study First Submitted QC: 2021-04-26
• Study First Posted: 2021-04-29
• Study Start: 2021-05-17
• Primary Completion: 2021-06-27
• Study Completion: 2021-06-27
• Status Verified: 2022-06
• Results First Submitted: 2022-06-09
• Results First Submitted QC: 2022-06-09
• Last Update Submitted: 2022-06-09
• Results First Posted: 2022-07-06
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

Not provided

Exclusion Criteria

• Habitual PRECISION1, Clariti 1-Day, and DAILIES TOTAL1 contact lens wearers.
• Any monovision and multifocal lens wearers.
• Other protocol-specified exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PRECISION1, then Clariti 1-Day	Somofilcon A contact lenses	Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 days in a daily disposable modality.
PRECISION1, then Clariti 1-Day	Verofilcon A contact lenses	Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 days in a daily disposable modality.
Clariti 1-Day, then PRECISION1	Verofilcon A contact lenses	Somofilcon 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) for 8 days in a daily disposable modality.
Clariti 1-Day, then PRECISION1	Somofilcon A contact lenses	Somofilcon 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) for 8 days in a daily disposable modality.

Primary Outcome Measures

Name	Time	Method
Least Squares Mean Distance VA (logMAR) With Study Lenses	Day 8, 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.

Trial Locations

Locations (8)

Alcon Investigator 6645; 🇺🇸 Shawnee Mission, Kansas, United States

Alcon Investigator 6418; 🇺🇸 Tallahassee, Florida, United States

Alcon Investigator 6402; 🇺🇸 Medina, Minnesota, United States

Alcon Investigator 8028; 🇺🇸 Wichita Falls, Texas, United States

Alcon Investigator 6614; 🇺🇸 Franklin Park, Illinois, United States

Alcon Investigator 8106; 🇺🇸 San Francisco, California, United States

Alcon Investigator 6565; 🇺🇸 Maitland, Florida, United States

Alcon Investigator 8046; 🇺🇸 Granville, Ohio, United States