Product Performance of a New Silicone Hydrogel Contact Lens

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: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: kalifilcon A; Device: delefilcon A; Device: senofilcon A

• Study Type: Interventional
• Enrollment (Actual): 805
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Mean Change in logMAR Contact Lens Visual Acuity	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"		2 Week Follow up
Percentage of Participants in the Test Lens Group Agreeing With the Statement "Provide Clear Vision Throughout the Day"		2 Week Follow up

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2019
• Primary Completion (Actual): October 9, 2019
• Study Completion (Actual): October 9, 2019

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID 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