Clinical trial NCT04901897: Product Performance of a New Silicone Hydrogel Contact Lens
Official title: A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2021-05-26
Enrollment: 805
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Mean Change in logMAR Contact Lens Visual Acuity
timeFrame: Baseline, 2 Week Follow up
measure: Percentage of Participants in the Test Lens Group Agreeing With the Statement "Are Comfortable Throughout the Day"
timeFrame: 2 Week Follow up
measure: Percentage of Participants in the Test Lens Group Agreeing With the Statement "Provide Clear Vision Throughout the Day"
timeFrame: 2 Week Follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Bausch Site 433
state: Alabama
city: Scottsdale
country: United States
facility: Bausch Site 431
state: Arizona
city: Azusa
country: United States
facility: Bausch Site 406
state: California
city: Los Angeles
country: United States
facility: Bausch Site 430
state: California
city: San Diego
country: United States
facility: Bausch Site 419
state: California
city: San Francisco
country: United States
facility: Bausch Site 435
state: California
city: Sunnyvale
country: United States
facility: Bausch Site 432
state: California
city: Torrance
country: United States
facility: Bausch Site 409
state: California
city: Denver
country: United States
facility: Bausch Site 416
state: Colorado
city: Jacksonville
country: United States
facility: Bausch Site 415
state: Florida
city: Jacksonville
country: United States
facility: Bausch Site 434
state: Florida
city: Sarasota
country: United States
facility: Bausch Site 405
state: Florida
city: Decatur
country: United States
facility: Bausch Site 412
state: Georgia
city: 'Aiea
country: United States
facility: Bausch Site 401
state: Hawaii
city: Honolulu
country: United States
facility: Bausch Site 437
state: Hawaii
city: Leavenworth
country: United States
facility: Bausch Site 414
state: Kansas
city: Portland
country: United States
facility: Bausch Site 413
state: Maine
city: Sterling Heights
country: United States
facility: Bausch Site 421
state: Michigan
city: Edina
country: United States
facility: Bausch Site 429
state: Minnesota
city: Raytown
country: United States
facility: Bausch Site 422
state: Missouri
city: Saint Louis
country: United States
facility: Bausch Site 407
state: Missouri
city: Warrensburg
country: United States
facility: Bausch Site 418
state: Missouri
city: Jamestown
country: United States
facility: Bausch Site 424
state: New York
city: Vestal
country: United States
facility: Bausch Site 403
state: New York
city: Raleigh
country: United States
facility: Bausch Site 417
state: North Carolina
city: Fargo
country: United States
facility: Bausch Site 411
state: North Dakota
city: Miamisburg
country: United States
facility: Bausch Site 423
state: Ohio
city: West Chester
country: United States
facility: Bausch Site 425
state: Ohio
city: Grants Pass
country: United States
facility: Bausch Site 428
state: Oregon
city: State College
country: United States
facility: Bausch Site 420
state: Pennsylvania
city: Warwick
country: United States
facility: Bausch Site 427
state: Rhode Island
city: Brentwood
country: United States
facility: Bausch 410
state: Tennessee
city: Memphis
country: United States
facility: Bausch Site 408
state: Tennessee
city: Nashville
country: United States
facility: Bausch Site 404
state: Tennessee
city: League City
country: United States
facility: Bausch Site 426
state: Texas
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Robert Steffen
role: STUDY_DIRECTOR
References: