Product Performance of a New Silicone Hydrogel Contact Lens

NCT04901897 | Completed Results FDA Device

• 1 other identifier: 893
• Study Type: interventional
• Target: 805
• Locations: 1 country
• Sites: 35

Brief Summary

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

kalifilcon A

EXPERIMENTAL

kalifilcon A daily disposable contact lens

Device: kalifilcon A

delefilcon A

ACTIVE COMPARATOR

DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses

Device: delefilcon A

senofilcon A

ACTIVE COMPARATOR

Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens

Device: senofilcon A

Interventions

kalifilcon A DEVICE

kalifilcon A daily disposable contact lens

kalifilcon A

delefilcon A DEVICE

DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses

delefilcon A

senofilcon A DEVICE

Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens

senofilcon A

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (35)

Bausch Site 433

Birmingham, Alabama, 35216, United States

Location

Bausch Site 431

Scottsdale, Arizona, 85254, United States

Location

Bausch Site 406

Azusa, California, 91702, United States

Location

Bausch Site 430

Los Angeles, California, 90013, United States

Location

Bausch Site 419

San Diego, California, 92123, United States

Location

Bausch Site 435

San Francisco, California, 94112, United States

Location

Bausch Site 432

Sunnyvale, California, 94087, United States

Location

Bausch Site 409

Torrance, California, 90503, United States

Location

Bausch Site 416

Denver, Colorado, 80246, United States

Location

Bausch Site 415

Jacksonville, Florida, 32256, United States

Location

Bausch Site 434

Jacksonville, Florida, 32256, United States

Location

Bausch Site 405

Sarasota, Florida, 34237, United States

Location

Bausch Site 412

Decatur, Georgia, 30035, United States

Location

Bausch Site 437

Honolulu, Hawaii, 96814, United States

Location

Bausch Site 401

‘Aiea, Hawaii, 96701, United States

Location

Bausch Site 414

Leavenworth, Kansas, 66048, United States

Location

Bausch Site 413

Portland, Maine, 04101, United States

Location

Bausch Site 421

Sterling Heights, Michigan, 48312, United States

Location

Bausch Site 429

Edina, Minnesota, 55436, United States

Location

Bausch Site 422

Raytown, Missouri, 64133, United States

Location

Bausch Site 407

St Louis, Missouri, 63144, United States

Location

Bausch Site 418

Warrensburg, Missouri, 64093, United States

Location

Bausch Site 424

Jamestown, New York, 14701, United States

Location

Bausch Site 403

Vestal, New York, 13850, United States

Location

Bausch Site 417

Raleigh, North Carolina, 27603, United States

Location

Bausch Site 411

Fargo, North Dakota, 58103, United States

Location

Bausch Site 423

Miamisburg, Ohio, 45342, United States

Location

Bausch Site 425

West Chester, Ohio, 45069, United States

Location

Bausch Site 428

Grants Pass, Oregon, 97526, United States

Location

Bausch Site 420

State College, Pennsylvania, 16801, United States

Location

Bausch Site 427

Warwick, Rhode Island, 02888, United States

Location

Bausch 410

Brentwood, Tennessee, 37027, United States

Location

Bausch Site 408

Memphis, Tennessee, 33119, United States

Location

Bausch Site 404

Nashville, Tennessee, 37205, United States

Location

Bausch Site 426

League City, Texas, 77573, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Daniel Donatello
• Organization: Bausch & Lomb

Daniel.Donatello@bausch.com

5853385306

Study Officials

• Robert Steffen

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 26, 2021
• Study Start: July 31, 2019
• Primary Completion: October 9, 2019
• Study Completion: October 9, 2019
• Last Updated: July 8, 2021
• Results First Posted: July 8, 2021

Record last verified: 2021-06

Locations

US (35)