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

NCT04942925 | Completed Results FDA Device

• 1 other identifier: CLE383-E002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Myopia; Ametropia

Keywords

Contact Lenses

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Precision1, then Infuse

OTHER

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.

Device: Verofilcon A contact lenses; Device: Kalifilcon A contact lenses

Infuse, then Precision1

OTHER

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.

Device: Verofilcon A contact lenses; Device: Kalifilcon A contact lenses

Interventions

Verofilcon A contact lenses DEVICE

Commercially available silicone hydrogel contact lenses for daily disposable wear

Also known as: PRECISION1™

Infuse, then Precision1; Precision1, then Infuse

Kalifilcon A contact lenses DEVICE

Commercially available silicone hydrogel contact lenses for daily disposable wear

Also known as: Bausch + Lomb INFUSE™

Infuse, then Precision1; Precision1, then Infuse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (4)

Alcon Investigator 6565

Maitland, Florida, 32751, United States

Location

Alcon Investigator 6355

Orlando, Florida, 32803, United States

Location

Alcon Investigator 6583

Eden Prairie, Minnesota, 55344, United States

Location

Alcon Investigator 6313

Powell, Ohio, 43065, United States

Location

MeSH Terms

Conditions

Myopia; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Sr. Project Lead, Vision Care
• Organization: Alcon Research, LLC

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Trial Lead, Vision Care

  Alcon Research, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will receive treatment based upon the randomized treatment sequence assignment

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 29, 2021
• Study Start: July 20, 2021
• Primary Completion: September 9, 2021
• Study Completion: September 9, 2021
• Last Updated: September 7, 2022
• Results First Posted: September 7, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)