Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens

Clinical Safety and Effectiveness Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens

The purpose of this clinical trial is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in an extended wear modality.

Study Overview

• Status: Completed
• Conditions: Refractive Ametropia
• Intervention / Treatment: Device: LID015385 soft contact lenses; Device: Comfilcon A soft contact lenses

Detailed Description

Subjects will be expected to attend 9 office visits. The total expected duration of participation for each subject is approximately 12 months.

• Study Type: Interventional
• Enrollment (Actual): 675
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Campbell, California, United States, 95008
      • Family Eyecare Center
    • Fullerton, California, United States, 92835
      • Winston Eye Care
    • Los Angeles, California, United States, 90013
      • East West Eye Institute
    • Los Angeles, California, United States, 90012
      • Kurata Eye Care Center
    • Oakland, California, United States, 94607
      • Dr.Elsa Pao, O.D
    • San Diego, California, United States, 92122
      • Gordon Schanzlin New Vision Institute
    • San Diego, California, United States, 92123
      • Complete Family Vision Care
    • San Diego, California, United States, 92129
      • Westview Optometry
  • Florida
    • Longwood, Florida, United States, 32779
      • OMEGA Vision Center PA, DBA Sabal Eye Care
    • Maitland, Florida, United States, 32751
      • Kindred Optics at Maitland Vision Center
    • Mount Dora, Florida, United States, 32757
      • Mid Florida Eye Center, PA
    • Orlando, Florida, United States, 32803
      • Vision Health Institute
    • Orlando, Florida, United States, 32803
      • Eola Eyes
    • Pensacola, Florida, United States, 32503
      • Visual Performance Center Research & Development
    • Sarasota, Florida, United States, 34237
      • Golden Vision
    • West Palm Beach, Florida, United States, 33405
      • Advanced Eyecare Specialists
  • Illinois
    • Bloomington, Illinois, United States, 61704
      • VisionPoint Eye Center
    • Franklin Park, Illinois, United States, 60131
      • Franklin Park Eye Center, PC
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Kannarr Eye Care, LLC
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • Optimum Vision Care
  • Michigan
    • Fraser, Michigan, United States, 48026
      • Fraser Eye Care Center
    • Sterling Heights, Michigan, United States, 48312
      • Dr. Schwartz Optometrist and Associates
  • Minnesota
    • Medina, Minnesota, United States, 55340
      • Complete Eye Care of Medina
    • Willmar, Minnesota, United States, 56201
      • Fischer Laser Eye Center, LLC
  • Missouri
    • Saint Louis, Missouri, United States, 63128
      • Tekwnai Vision Center, Inc
  • New York
    • Poughkeepsie, New York, United States, 12603
      • Alterman, Modi & Wolter
    • Rochester, New York, United States, 14618
      • Rochester Ophthalmological Group, PC
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Asheville Eye Associates, PLLC
  • Ohio
    • Granville, Ohio, United States, 43023
      • Procare Vision Centers, Inc.
    • Piqua, Ohio, United States, 45356
      • Midwest Vision Care
    • Powell, Ohio, United States, 43065
      • EyeCare Professionals, Inc. DBA Insight Research Clinic, LLC
  • Pennsylvania
    • Wyomissing, Pennsylvania, United States, 19610
      • Wyomissing Optometric Center
  • Rhode Island
    • Warwick, Rhode Island, United States, 02888
      • West Bay Eye Associates
  • South Carolina
    • Boiling Springs, South Carolina, United States, 29316
      • North Spartanburg Eye Center
  • Tennessee
    • Brentwood, Tennessee, United States, 37027
      • Primary Eyecare Group, PC
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care, PA
    • Memphis, Tennessee, United States, 38111
      • Optometry Group, PLLC
    • Smyrna, Tennessee, United States, 37167
      • Advancing Vision Research, LLC
  • Texas
    • Beaumont, Texas, United States, 77706
      • Beaumont Family Eye Care
    • Katy, Texas, United States, 77450
      • Vision One Eyecare
    • San Antonio, Texas, United States, 78213
      • Dawn M Rakich, OD
    • Wichita Falls, Texas, United States, 76308
      • Clarke EyeCare Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Able to understand and sign an Informed Consent Form.
• Willing to attend all scheduled study visits as required per protocol.
• Willing and able to wear assigned study lenses as required per protocol.
• Successful wear of spherical daily wear or extended wear frequent replacement soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week.
• Manifest cylinder ≤ 0.75 diopter (D) in each eye.
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Any eye infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator.
• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
• History of eye surgery, including refractive surgery.
• Currently pregnant or breast-feeding.
• Monovision contact lens wearers.
• Daily disposable contact lens wearers.
• Other protocol-specified 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 soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must sleep 1 night per week without lenses. Lenses will be replaced as specified in the study protocol.	Device: LID015385 soft contact lenses; Investigational silicone hydrogel contact lenses for up to 6 nights/7 days of continuous wear
Active Comparator: Biofinity; Comfilcon A soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must sleep 1 night per week without lenses. Lenses will be replaced as specified in the study protocol.	Device: Comfilcon A soft contact lenses; Silicone hydrogel contact lenses for up to 6 nights/7 days of continuous wear; Other Names: BIOFINITY®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance Visual Acuity (VA) With Study Lenses - Completed Eyes	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 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. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.	Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up, Month 12 Follow-up
Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes	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 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. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.	Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up
Proportion of Ocular Serious and Significant Non-serious Adverse Device Effects (ADEs)	Calculated as the total number of eyes reporting at least one treatment-emergent, ocular, serious ADE or treatment-emergent, ocular, significant, non-serious ADE, divided by the total number of eyes enrolled and dispensed. An ADE was defined as any adverse event related to the use of the investigational medical device (LID015385) or control product (Biofinity).	Up to Month 12

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Alcon Study Director, Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2019
• Primary Completion (Actual): March 26, 2021
• Study Completion (Actual): March 26, 2021

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (Actual): September 11, 2019

Study Record Updates

• Last Update Posted (Actual): June 13, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLL949-C010

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