Product Performance of a New Silicone Hydrogel Contact Lens

Not Applicable

Completed

Conditions: Myopia

Interventions: Device: kalifilcon A
Device: delefilcon A
Device: senofilcon A

Registration Number: NCT04901897

Lead Sponsor: Bausch & Lomb Incorporated

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 805

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
kalifilcon A	kalifilcon A	kalifilcon A daily disposable contact lens
delefilcon A	delefilcon A	DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses
senofilcon A	senofilcon A	Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens

Primary Outcome Measures

Name	Time	Method
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
Mean Change in logMAR Contact Lens Visual Acuity	Baseline, 2 Week Follow up	logMAR is the logarithm of the minim angle of resolution

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (35): Bausch Site 431
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Scottsdale, Arizona, United States
Bausch Site 406
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Azusa, California, United States
Bausch Site 430
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Los Angeles, California, United States
Bausch Site 432
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Sunnyvale, California, United States
Bausch Site 409
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Torrance, California, United States
Bausch Site 415
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Jacksonville, Florida, United States
Bausch Site 434
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Jacksonville, Florida, United States
Bausch Site 405
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Sarasota, Florida, United States
Bausch Site 401
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'Aiea, Hawaii, United States
Bausch Site 412
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Decatur, Georgia, United States
Bausch Site 421
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Sterling Heights, Michigan, United States
Bausch Site 413
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Portland, Maine, United States
Bausch Site 429
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Edina, Minnesota, United States
Bausch Site 422
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Raytown, Missouri, United States
Bausch Site 407
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Saint Louis, Missouri, United States
Bausch Site 418
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Warrensburg, Missouri, United States
Bausch Site 424
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Jamestown, New York, United States
Bausch Site 403
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Vestal, New York, United States
Bausch Site 417
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Raleigh, North Carolina, United States
Bausch Site 411
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Fargo, North Dakota, United States
Bausch Site 423
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Miamisburg, Ohio, United States
Bausch Site 425
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West Chester, Ohio, United States
Bausch Site 428
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Grants Pass, Oregon, United States
Bausch Site 427
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Warwick, Rhode Island, United States
Bausch Site 408
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Memphis, Tennessee, United States
Bausch Site 426
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League City, Texas, United States
Bausch Site 419
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San Diego, California, United States
Bausch Site 414
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Leavenworth, Kansas, United States
Bausch Site 435
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San Francisco, California, United States
Bausch Site 404
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Nashville, Tennessee, United States
Bausch Site 433
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Birmingham, Alabama, United States
Bausch Site 416
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Denver, Colorado, United States
Bausch 410
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Brentwood, Tennessee, United States
Bausch Site 420
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State College, Pennsylvania, United States
Bausch Site 437
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Honolulu, Hawaii, United States