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

Not Applicable

Completed

• Conditions: Myopia; Ametropia
• Interventions: Device: Verofilcon A contact lenses; Device: Kalifilcon A contact lenses

• Registration Number: NCT04942925
• Lead Sponsor: Alcon Research

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2021-06-21
• Study First Submitted QC: 2021-06-21
• Study First Posted: 2021-06-29
• Study Start: 2021-07-20
• Primary Completion: 2021-09-09
• Study Completion: 2021-09-09
• Status Verified: 2022-08
• Results First Submitted: 2022-08-16
• Results First Submitted QC: 2022-08-16
• Last Update Submitted: 2022-08-16
• Results First Posted: 2022-09-07
• Last Update Posted: 2022-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Precision1, then Infuse	Kalifilcon A contact lenses	Verofilcon A contact lenses worn first, with kalifilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.
Infuse, then Precision1	Kalifilcon A contact lenses	Kalifilcon 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 -0/+3 days in a daily disposable modality.
Infuse, then Precision1	Verofilcon A contact lenses	Kalifilcon 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 -0/+3 days in a daily disposable modality.
Precision1, then Infuse	Verofilcon A contact lenses	Verofilcon A contact lenses worn first, with kalifilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.

Primary Outcome Measures

Name	Time	Method
Distance VA (logMAR) With Study Lenses	Day 8 (-0/+3 days), 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. No inferential testing was pre-specified for this endpoint.

Trial Locations

Locations (4)

Alcon Investigator 6313; 🇺🇸 Powell, Ohio, United States

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

Alcon Investigator 6355; 🇺🇸 Orlando, Florida, United States

Alcon Investigator 6583; 🇺🇸 Eden Prairie, Minnesota, United States