Clinical Performance Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens

NCT04055519 | Completed Results FDA Device

• 1 other identifier: CLY935-C007
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to obtain on-eye performance data to inform contact lens product development.

Conditions

Refractive Errors

Keywords

Contact Lenses

Outcome Measures

Primary Outcomes (1)

• Distance VA (logMAR) With Study Lenses

  Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.

  Day 30 after a minimum of 6 hours of wear, each product

Study Arms (2)

LID017569, then Biofinity

OTHER

Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection.

Device: Lehfilcon A contact lenses; Device: Comfilcon A contact lenses; Device: Multi-purpose disinfection solution

Biofinity, then LID017569

OTHER

Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection.

Device: Lehfilcon A contact lenses; Device: Comfilcon A contact lenses; Device: Multi-purpose disinfection solution

Interventions

Lehfilcon A contact lenses DEVICE

Investigational silicone hydrogel contact lenses

Also known as: LID017569

Biofinity, then LID017569; LID017569, then Biofinity

Comfilcon A contact lenses DEVICE

Commercially available silicone hydrogel contact lenses

Also known as: Biofinity®

Biofinity, then LID017569; LID017569, then Biofinity

Multi-purpose disinfection solution DEVICE

Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses

Also known as: OPTI-FREE® RepleniSH®

Biofinity, then LID017569; LID017569, then Biofinity

Eligibility Criteria

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

You may qualify if:

• Sign Informed Consent document.
• Successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
• Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes.

You may not qualify if:

• Any eye condition or disease or use of medication that contraindicates contact lens wear.
• Eye surgery, irregular cornea, eye injury as specified in the protocol.
• Routinely sleeps in contact lenses at least 1 night per week over the last 3 months prior to enrollment.
• Any use of topical ocular medications, artificial tear or rewetting drops that would require instillation during contact lens wear.
• Habitually wears Biofinity contact lenses.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (3)

Alcon Investigative Site

Maitland, Florida, 32751, United States

Location

Alcon Investigative Site

Bloomington, Illinois, 61704, United States

Location

Alcon Investigative Site

Memphis, Tennessee, 38111, United States

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

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

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• CDMA Project 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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 13, 2019
• Study Start: September 19, 2019
• Primary Completion: December 3, 2019
• Study Completion: December 3, 2019
• Last Updated: May 13, 2021
• Results First Posted: May 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)