Clinical Comparison of Two Daily Disposable Contact Lenses

Refractive Errors Clinical Trial

Official title:

Clinical Comparison of Two Daily Disposable Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04865354
• Other study ID #: CLE383-P005
• Status: Completed
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: June 27, 2021

Study information

• Verified date: June 2022
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: June 27, 2021
• Est. primary completion date: June 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria

• Successful wearer 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.
• Possess spectacles and 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 one of the days (day prior to each week 1 visit).
• Other protocol-specified inclusion criteria may apply.

Key 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.

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• Verofilcon A contact lenses
Spherical soft contact lenses for daily disposable wear
• Somofilcon A contact lenses
Spherical soft contact lenses for daily disposable wear

Locations

Country	Name	City	State
United States	Alcon Investigator 6614	Franklin Park	Illinois
United States	Alcon Investigator 8046	Granville	Ohio
United States	Alcon Investigator 6565	Maitland	Florida
United States	Alcon Investigator 6402	Medina	Minnesota
United States	Alcon Investigator 8106	San Francisco	California
United States	Alcon Investigator 6645	Shawnee Mission	Kansas
United States	Alcon Investigator 6418	Tallahassee	Florida
United States	Alcon Investigator 8028	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Least Squares Mean Distance VA (logMAR) With Study Lenses	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.	Day 8, each study lens type