Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses

NCT04532099 | Completed Results FDA Device

• 1 other identifier: CLY935-C020
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 4

Brief Summary

The primary objective of this study is to evaluate the overall performance of an investigational silicone hydrogel lens when compared to ACUVUE OASYS® with HYDRACLEAR® PLUS (AOHP).

Conditions

Refractive Errors; Ametropia

Keywords

Contact Lenses

Outcome Measures

Primary Outcomes (1)

• Distance Visual Acuity (VA) (Part A)

  Distance 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 formal hypothesis testing was predefined for the primary endpoint. The primary endpoint was prespecified for Part A only.

  Day 30, each study lens type

Study Arms (3)

LID018869, then AOHP (Part A)

OTHER

Lehfilcon A contact lenses worn first, followed by senofilcon A contact lenses, as randomized. Each product will be worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.

Device: Lehfilcon A contact lenses; Device: Senofilcon A contact lenses; Device: Hydrogen peroxide-based cleaning and disinfecting solution

AOHP, then LID018869 (Part A)

OTHER

Senofilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.

Device: Lehfilcon A contact lenses; Device: Senofilcon A contact lenses; Device: Hydrogen peroxide-based cleaning and disinfecting solution

Biofinity (Part B)

ACTIVE COMPARATOR

Comfilcon A contact lenses worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of the wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.

Device: Comfilcon A contact lenses; Device: Hydrogen peroxide-based cleaning and disinfecting solution

Interventions

Lehfilcon A contact lenses DEVICE

Investigational soft contact lenses for daily wear worn in Part A of the study

Also known as: LID018869

AOHP, then LID018869 (Part A); LID018869, then AOHP (Part A)

Senofilcon A contact lenses DEVICE

Commercially available soft contact lenses for daily wear worn in Part A of the study

Also known as: AOHP, ACUVUE OASYS® with HYDRACLEAR® PLUS

AOHP, then LID018869 (Part A); LID018869, then AOHP (Part A)

Comfilcon A contact lenses DEVICE

Commercially available soft contact lenses for daily wear worn in Part B of the study

Also known as: CooperVision® Biofinity®

Biofinity (Part B)

Hydrogen peroxide-based cleaning and disinfecting solution DEVICE

For nightly cleaning and disinfecting of contact lenses in Part A and Part B of the study

Also known as: CLEAR CARE®

AOHP, then LID018869 (Part A); Biofinity (Part B); LID018869, then AOHP (Part A)

Eligibility Criteria

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

You may qualify if:

• Sign an approved Informed Consent Form.
• Wear spherical contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
• Willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.

You may not qualify if:

• Any eye condition or use of medication that contraindicates contact lens wear, as determined by the Investigator.
• History of refractive surgery or plan to have refractive surgery during the study.
• Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear.
• Routinely sleeps in contact lenses at least 1 night per week.
• Part A: Current wearer of ACUVUE OASYS® with HYDRACLEAR® PLUS.
• Part B: Current wearer of Biofinity family of contact lenses (comfilcon A).

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (4)

Alcon Investigator 6356

Longwood, Florida, 32779, United States

Location

Alcon Investigator 6565

Maitland, Florida, 32751, United States

Location

Alcon Investigator 6401

Warwick, Rhode Island, 02888, United States

Location

Alcon Investigator 6353

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

• Sr. Clinical Trial Lead, CDMA 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
• Masking Details: Part A is double masked. Part B is single masked (trial subject).
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A is a crossover study. Part B is a single group study.

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 31, 2020
• Study Start: September 9, 2020
• Primary Completion: May 4, 2021
• Study Completion: May 4, 2021
• Last Updated: May 3, 2022
• Results First Posted: May 3, 2022

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)