Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens

September 29, 2021 updated by: Alcon Research
The purpose of this clinical study is to evaluate the safety and effectiveness of an investigational soft contact lens compared to a commercially available soft contact lens when worn for daily wear and replaced monthly.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects are expected to attend 6 study visits. The expected duration of study lens exposure is approximately 3 months.

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Longwood, Florida, United States, 32779
        • Alcon Investigative Site
      • Maitland, Florida, United States, 32751
        • Alcon Investigative Site
      • Orlando, Florida, United States, 32803
        • Alcon Investigative Site
    • Illinois
      • Bloomington, Illinois, United States, 61704
        • Alcon Investigative Site
    • Minnesota
      • Medina, Minnesota, United States, 55340
        • Alcon Investigative Site
    • Ohio
      • Granville, Ohio, United States, 43023
        • Alcon Investigative Site
    • Tennessee
      • Memphis, Tennessee, United States, 38111
        • Alcon Investigative Site
      • Memphis, Tennessee, United States, 38119
        • Alcon Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 equal to or less than 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.
  • Habitually wearing Biofinity contact lenses.
  • Monovision contact lens wearers.
  • Other protocol-specified exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LID018869
Lehfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only. The lenses will be removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.
Device: Lehfilcon A contact lenses
Investigational silicone hydrogel contact lenses
Other Names:
  • LID018869
Device: CLEAR CARE
Hydrogen peroxide-based system for cleaning and disinfecting silicone hydrogel contact lenses
Other Names:
  • CLEAR CARE® Cleaning & Disinfecting Solution
Active Comparator: Biofinity
Comfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only. The lenses will be removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.
Device: CLEAR CARE
Hydrogen peroxide-based system for cleaning and disinfecting silicone hydrogel contact lenses
Other Names:
  • CLEAR CARE® Cleaning & Disinfecting Solution
Device: Comfilcon A contact lenses
Commercially available silicone hydrogel contact lenses
Other Names:
  • Biofinity
  • CooperVision® BIOFINITY®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distance VA (logMAR) With Study Lenses - Completed Eyes
Time Frame: Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up, Month 2 follow-up, Month 3 follow-up (at least 4 hours after lens insertion at each follow-up assessment visit)
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 a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up, Month 2 follow-up, Month 3 follow-up (at least 4 hours after lens insertion at each follow-up assessment visit)
Distance VA (logMAR) With Study Lenses - Discontinued Eyes
Time Frame: Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up
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 a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2020

Primary Completion (Actual)

June 10, 2020

Study Completion (Actual)

June 10, 2020

Study Registration Dates

First Submitted

November 25, 2019

First Submitted That Met QC Criteria

November 25, 2019

First Posted (Actual)

November 26, 2019

Study Record Updates

Last Update Posted (Actual)

October 19, 2021

Last Update Submitted That Met QC Criteria

September 29, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLY935-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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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