Product Performance of a New Silicone Hydrogel Contact Lens

June 17, 2021 updated by: Bausch & Lomb Incorporated

A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens

The objective of this study is to evaluate the product performance of kalifilcon A, compared to the Johnson & Johnson Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens and Alcon DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses when worn by current soft contact lens wearers on a daily disposable wear basis.

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.

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.
805

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
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Bausch Site 433
    • Arizona
      • Scottsdale, Arizona, United States, 85254
        • Bausch Site 431
    • California
      • Azusa, California, United States, 91702
        • Bausch Site 406
      • Los Angeles, California, United States, 90013
        • Bausch Site 430
      • San Diego, California, United States, 92123
        • Bausch Site 419
      • San Francisco, California, United States, 94112
        • Bausch Site 435
      • Sunnyvale, California, United States, 94087
        • Bausch Site 432
      • Torrance, California, United States, 90503
        • Bausch Site 409
    • Colorado
      • Denver, Colorado, United States, 80246
        • Bausch Site 416
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Bausch Site 415
      • Jacksonville, Florida, United States, 32256
        • Bausch Site 434
      • Sarasota, Florida, United States, 34237
        • Bausch Site 405
    • Georgia
      • Decatur, Georgia, United States, 30035
        • Bausch Site 412
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • Bausch Site 401
      • Honolulu, Hawaii, United States, 96814
        • Bausch Site 437
    • Kansas
      • Leavenworth, Kansas, United States, 66048
        • Bausch Site 414
    • Maine
      • Portland, Maine, United States, 04101
        • Bausch Site 413
    • Michigan
      • Sterling Heights, Michigan, United States, 48312
        • Bausch Site 421
    • Minnesota
      • Edina, Minnesota, United States, 55436
        • Bausch Site 429
    • Missouri
      • Raytown, Missouri, United States, 64133
        • Bausch Site 422
      • Saint Louis, Missouri, United States, 63144
        • Bausch Site 407
      • Warrensburg, Missouri, United States, 64093
        • Bausch Site 418
    • New York
      • Jamestown, New York, United States, 14701
        • Bausch Site 424
      • Vestal, New York, United States, 13850
        • Bausch Site 403
    • North Carolina
      • Raleigh, North Carolina, United States, 27603
        • Bausch Site 417
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Bausch Site 411
    • Ohio
      • Miamisburg, Ohio, United States, 45342
        • Bausch Site 423
      • West Chester, Ohio, United States, 45069
        • Bausch Site 425
    • Oregon
      • Grants Pass, Oregon, United States, 97526
        • Bausch Site 428
    • Pennsylvania
      • State College, Pennsylvania, United States, 16801
        • Bausch Site 420
    • Rhode Island
      • Warwick, Rhode Island, United States, 02888
        • Bausch Site 427
    • Tennessee
      • Brentwood, Tennessee, United States, 37027
        • Bausch 410
      • Memphis, Tennessee, United States, 33119
        • Bausch Site 408
      • Nashville, Tennessee, United States, 37205
        • Bausch Site 404
    • Texas
      • League City, Texas, United States, 77573
        • Bausch Site 426

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 to 40 years old on the date the ICF is signed and have capacity to provide voluntary informed consent.
  • myopic and require lens correction from -0.50 to -6.00 Diopter (D) with 0.25 D steps, in each eye.
  • correctable through spherocylindrical refraction and with soft spherical contact lenses to 32 letters (0.3 logarithm of the minimum angle of resolution [logMAR]) or better (2 meters distance, high-contrast chart) in each eye.
  • free of any anterior segment disorders.
  • adapted soft contact lens wearers and willing to wear their study lenses for at least 8 hours per day on a daily disposable wear basis for approximately 2 weeks.
  • access to internet connection and personal email to send/receive emails.
  • habitually wear either Alcon's Air Optix Aqua, Air Optix with HydraGlyde, Air Optix Night & Day, Bausch + Lomb's PureVision 2, Bausch + Lomb ULTRA, CooperVision's Biofinity, Johnson & Johnson Acuvue Oasys® with HydraClear™, or Acuvue Vita soft contact lenses.

Exclusion Criteria:

  • participating in any drug or device clinical investigation within 2 weeks prior to entry into this study (Screening/Dispensing Visit) and/or during the period of study participation.
  • have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
  • have any systemic or ocular disease currently affecting ocular health in the Investigator's opinion may have an effect on ocular health during the course of the study.
  • using any systemic, topical or topical ocular medications that will in the Investigator's opinion, affect ocular physiology or lens performance.currently wear daily disposable, monovision, multifocal, or toric contact lenses.
  • refractive astigmatism of greater than 0.75 D in either eye.
  • anisometropia (spherical equivalent) of greater than 2.00 D.
  • amblyopic.
  • have had any corneal surgery (e.g., refractive surgery).

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: Single

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: kalifilcon A
kalifilcon A daily disposable contact lens
Device: kalifilcon A
kalifilcon A daily disposable contact lens
Active Comparator: delefilcon A
DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses
Device: delefilcon A
DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses
Active Comparator: senofilcon A
Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens
Device: senofilcon A
Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens

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
Mean Change in logMAR Contact Lens Visual Acuity
Time Frame: Baseline, 2 Week Follow up
logMAR is the logarithm of the minim angle of resolution
Baseline, 2 Week Follow up
Percentage of Participants in the Test Lens Group Agreeing With the Statement "Are Comfortable Throughout the Day"
Time Frame: 2 Week Follow up
2 Week Follow up
Percentage of Participants in the Test Lens Group Agreeing With the Statement "Provide Clear Vision Throughout the Day"
Time Frame: 2 Week Follow up
2 Week Follow up

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.
Bausch & Lomb Incorporated

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.
July 31, 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.
October 9, 2019

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.
October 9, 2019

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).
May 21, 2021

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.
May 21, 2021

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.
May 26, 2021

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.
July 8, 2021

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.
June 17, 2021

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.
June 1, 2021

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.
  • 893

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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

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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