Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens

The purpose of this clinical study is to assess the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality with frequent replacement.

Study Overview

• Status: Completed
• Conditions: Refractive Errors; Myopia; Hyperopia
• Intervention / Treatment: Device: LID015385 contact lenses; Device: CLEAR CARE; Device: Comfilcon A contact lenses

Detailed Description

Subjects will attend 4 office visits: Screening/Baseline/Dispense; Week 1 Follow-up; Month 1 Follow-up; and Month 3 Follow-up/Exit. The total expected duration of participation for each subject is approximately 3 months.

• Study Type: Interventional
• Enrollment (Actual): 249
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Alcon Investigator 8103
  • California
    • Brentwood, California, United States, 94513
      • Alcon Investigator 8101
    • Irvine, California, United States, 92618
      • Alcon Investigator 8102
    • Los Angeles, California, United States, 90012
      • Alcon Investigator 8135
    • Novato, California, United States, 94945
      • Alcon Investigator 8108
    • Oakland, California, United States, 94607
      • Alcon Investigator 8062
    • San Francisco, California, United States, 94127
      • Alcon Investigator 8109
  • Florida
    • Maitland, Florida, United States, 32751
      • Alcon Investigator 6565
    • Orlando, Florida, United States, 32803
      • Alcon Investigator 6355
  • Georgia
    • Norcross, Georgia, United States, 30071
      • Alcon Investigator 8115
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Alcon Investigator 6567
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • Alcon Investigator 8063
  • New York
    • New York, New York, United States, 10036
      • Alcon Investigator 8100
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Alcon Investigator 4817
    • Powell, Ohio, United States, 43065
      • Alcon Investigator 6313
  • Rhode Island
    • Warwick, Rhode Island, United States, 02888
      • Alcon Investigator 6401
  • Tennessee
    • Memphis, Tennessee, United States, 38111
      • Alcon Investigator 6353
  • Texas
    • Plano, Texas, United States, 75093
      • Alcon Investigator 8114

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:

• Understand and sign an IRB/IEC approved Informed Consent form.
• Willing and able to attend all scheduled study visits and wear the assigned study lenses as required per protocol.
• Successful wear of frequent replacement, spherical, daily wear soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
• Manifest cylinder ≤ 0.75 diopter (D) in each eye.
• Best spectacle corrected visual acuity 20/20 or better in each eye.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
• Monovision contact lens wear.
• Any habitual wear of Biofinity lenses.
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LID015385; LID015385 contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE will be used for nightly cleaning and disinfection.	Device: LID015385 contact lenses; Investigational soft contact lenses; Device: CLEAR CARE; Hydrogen peroxide-based cleaning and disinfecting solution
Active Comparator: Biofinity; Comfilcon A contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE will be used for nightly cleaning and disinfection.	Device: CLEAR CARE; Hydrogen peroxide-based cleaning and disinfecting solution; Device: Comfilcon A contact lenses; Commercially available soft contact lenses; Other Names: BIOFINITY®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009)	Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.	Week 1 Follow-Up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye (CLL949-C018 + CLL949-C009)	Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen, with 20/20 Snellen visual acuity considered normal distance eyesight.	Week 1 Follow-Up, at least 4 hours after lens insertion

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2020
• Primary Completion (Actual): December 17, 2020
• Study Completion (Actual): December 17, 2020

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: December 19, 2019
• First Posted (Actual): December 23, 2019

Study Record Updates

• Last Update Posted (Actual): February 2, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Contact Lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Hyperopia
• Other Study ID Numbers: CLL949-C018

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