Clinical Evaluation of a Daily Wear Frequent Replacement Silicone Hydrogel Lens

The purpose of this clinical study is to demonstrate 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.

Study Overview

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

Detailed Description

Subjects will be randomized to wear either the investigational contact lenses or the commercially available contact lenses in both eyes. Subjects will be expected to attend 6 scheduled study visits. Individual participation in the study will be approximately 3 months.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Maitland, Florida, United States, 32751
      • Alcon Investigator 6565
    • Orlando, Florida, United States, 32803
      • Alcon Investigator 6355
    • Pensacola, Florida, United States, 32503
      • Alcon Investigator 6291
  • Illinois
    • Bloomington, Illinois, United States, 61704
      • Alcon Investigator 3950
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Alcon Investigator 6567
  • Ohio
    • 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

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:

• Successful wear of spherical daily wear frequent replacement 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.
• Other protocol-specified 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 wearers.
• Habitually wearing Biofinity® lenses.
• 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 contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses will be removed nightly for cleaning with CLEAR CARE.	Device: LID015385 contact lenses; Investigational silicone hydrogel contact lenses; Device: CLEAR CARE; Hydrogen peroxide-based cleaning and disinfecting system
Active Comparator: Biofinity; Comfilcon A contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses will be removed nightly for cleaning with CLEAR CARE.	Device: CLEAR CARE; Hydrogen peroxide-based cleaning and disinfecting system; Device: Comfilcon A soft contact lenses; Commercially available silicone hydrogel contact lenses; 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 testing was planned.	Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up/Exit (at least 4 hours after lens insertion at each follow-up assessment visit)
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 the logarithm minimum angle of resolution (logMAR) scale. 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 testing was planned.	Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 Follow-up (at least 4 hours after lens insertion at each follow-up assessment visit)

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: CDMA Project Lead, Vision Care, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2019
• Primary Completion (Actual): October 5, 2019
• Study Completion (Actual): October 5, 2019

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (Actual): April 18, 2019

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Contact Lens; Daily Wear; Vision Correction
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLL949-C009

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