Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3

Myopia Clinical Trial

Official title:

Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04942925
• Other study ID #: CLE383-E002
• Status: Completed
• Phase: N/A
• Start date: July 20, 2021
• Est. completion date: September 9, 2021

Study information

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

Clinical Trial Summary

The purpose of this study is to evaluate the overall performance of PRECISION1™ contact lenses when compared to INFUSE™ contact lenses.

Description:

The expected duration of subject participation in the study is up to 24 days with 3 scheduled visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 9, 2021
• Est. primary completion date: September 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Able to understand and sign an Informed Consent Form that been approved by an Institutional Review Board.
• Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Current/previous PRECISION1 or INFUSE contact lens wearer.
• Any eye condition or use of medication that contraindicates contact lens wear, as determined by the investigator.
• Routinely sleeps in contact lenses.
• Other protocol-defined exclusion criteria may apply.

Related Conditions & MeSH terms

• Ametropia
• Myopia
• Refractive Errors

Intervention

Device:
• Verofilcon A contact lenses
Commercially available silicone hydrogel contact lenses for daily disposable wear
• Kalifilcon A contact lenses
Commercially available silicone hydrogel contact lenses for daily disposable wear

Locations

Country	Name	City	State
United States	Alcon Investigator 6583	Eden Prairie	Minnesota
United States	Alcon Investigator 6565	Maitland	Florida
United States	Alcon Investigator 6355	Orlando	Florida
United States	Alcon Investigator 6313	Powell	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. No inferential testing was pre-specified for this endpoint.	Day 8 (-0/+3 days), each study lens type