Product Performance of a New Silicone Hydrogel Contact Lens
NCT ID: NCT04901897
Last Updated: 2021-07-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
805 participants
INTERVENTIONAL
2019-07-31
2019-10-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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kalifilcon A
kalifilcon A daily disposable contact lens
kalifilcon A
kalifilcon A daily disposable contact lens
delefilcon A
DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses
delefilcon A
DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses
senofilcon A
Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens
senofilcon A
Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens
Interventions
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kalifilcon A
kalifilcon A daily disposable contact lens
delefilcon A
DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses
senofilcon A
Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
40 Years
ALL
No
Sponsors
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Bausch & Lomb Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Steffen
Role: STUDY_DIRECTOR
Bausch & Lomb Incorporated
Locations
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Bausch Site 433
Birmingham, Alabama, United States
Bausch Site 431
Scottsdale, Arizona, United States
Bausch Site 406
Azusa, California, United States
Bausch Site 430
Los Angeles, California, United States
Bausch Site 419
San Diego, California, United States
Bausch Site 435
San Francisco, California, United States
Bausch Site 432
Sunnyvale, California, United States
Bausch Site 409
Torrance, California, United States
Bausch Site 416
Denver, Colorado, United States
Bausch Site 415
Jacksonville, Florida, United States
Bausch Site 434
Jacksonville, Florida, United States
Bausch Site 405
Sarasota, Florida, United States
Bausch Site 412
Decatur, Georgia, United States
Bausch Site 437
Honolulu, Hawaii, United States
Bausch Site 401
‘Aiea, Hawaii, United States
Bausch Site 414
Leavenworth, Kansas, United States
Bausch Site 413
Portland, Maine, United States
Bausch Site 421
Sterling Heights, Michigan, United States
Bausch Site 429
Edina, Minnesota, United States
Bausch Site 422
Raytown, Missouri, United States
Bausch Site 407
St Louis, Missouri, United States
Bausch Site 418
Warrensburg, Missouri, United States
Bausch Site 424
Jamestown, New York, United States
Bausch Site 403
Vestal, New York, United States
Bausch Site 417
Raleigh, North Carolina, United States
Bausch Site 411
Fargo, North Dakota, United States
Bausch Site 423
Miamisburg, Ohio, United States
Bausch Site 425
West Chester, Ohio, United States
Bausch Site 428
Grants Pass, Oregon, United States
Bausch Site 420
State College, Pennsylvania, United States
Bausch Site 427
Warwick, Rhode Island, United States
Bausch 410
Brentwood, Tennessee, United States
Bausch Site 408
Memphis, Tennessee, United States
Bausch Site 404
Nashville, Tennessee, United States
Bausch Site 426
League City, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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893
Identifier Type: -
Identifier Source: org_study_id
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