Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens

May 19, 2023 updated by: Alcon Research

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
675

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Distance Visual Acuity (VA) With Study Lenses - Completed Eyes
Time Frame: 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
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
Time Frame: 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
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)
Time Frame: Up to Month 12
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

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alcon Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Alcon Study Director, Alcon Research

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 11, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 26, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 26, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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