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

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).

Study Overview

• Status: Completed
• Conditions: Refractive Errors; Ametropia
• Intervention / Treatment: Device: Lehfilcon A contact lenses; Device: Senofilcon A contact lenses; Device: Hydrogen peroxide-based cleaning and disinfecting solution; Device: Comfilcon A contact lenses

Detailed Description

Part A of this study is a randomized, double masked, crossover study comparing 2 contact lens products. The expected duration of subject participation in Part A is approximately 8 weeks with 5 scheduled visits.

Part B of this study is a non-randomized, single masked, single group study with 1 contact lens product. The expected duration of subject participation in Part B is approximately 4 weeks with 3 scheduled visits.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Longwood, Florida, United States, 32779
      • Alcon Investigator 6356
    • Maitland, Florida, United States, 32751
      • Alcon Investigator 6565
  • Rhode Island
    • Warwick, Rhode Island, United States, 02888
      • Alcon Investigator 6401
  • Tennessee
    • Memphis, Tennessee, United States, 38111
      • Alcon Investigator 6353

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• 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.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• 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).
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: LID018869, then AOHP (Part A); 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; Investigational soft contact lenses for daily wear worn in Part A of the study; Other Names: LID018869; Device: Senofilcon A contact lenses; Commercially available soft contact lenses for daily wear worn in Part A of the study; Other Names: AOHP; ACUVUE OASYS® with HYDRACLEAR® PLUS; Device: Hydrogen peroxide-based cleaning and disinfecting solution; For nightly cleaning and disinfecting of contact lenses in Part A and Part B of the study; Other Names: CLEAR CARE®
OTHER: AOHP, then LID018869 (Part A); 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; Investigational soft contact lenses for daily wear worn in Part A of the study; Other Names: LID018869; Device: Senofilcon A contact lenses; Commercially available soft contact lenses for daily wear worn in Part A of the study; Other Names: AOHP; ACUVUE OASYS® with HYDRACLEAR® PLUS; Device: Hydrogen peroxide-based cleaning and disinfecting solution; For nightly cleaning and disinfecting of contact lenses in Part A and Part B of the study; Other Names: CLEAR CARE®
ACTIVE_COMPARATOR: Biofinity (Part B); 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: Hydrogen peroxide-based cleaning and disinfecting solution; For nightly cleaning and disinfecting of contact lenses in Part A and Part B of the study; Other Names: CLEAR CARE®; Device: Comfilcon A contact lenses; Commercially available soft contact lenses for daily wear worn in Part B of the study; Other Names: CooperVision® Biofinity®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 9, 2020
• Primary Completion (ACTUAL): May 4, 2021
• Study Completion (ACTUAL): May 4, 2021

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (ACTUAL): August 31, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 3, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Contact Lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Anti-Infective Agents, Local; Anti-Infective Agents; Hydrogen Peroxide
• Other Study ID Numbers: CLY935-C020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No