Product Performance of a New Silicone Hydrogel Contact Lens
Completed · Not applicable
Conditions studied: Myopia
In brief
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.
Key facts
- Study ID
- NCT04901897
- Run by
- Bausch & Lomb Incorporated
- People needed
- 805
- Starts
- 2019-07-31
- Expected to finish
- 2019-10-09
- Last updated by the study team
- 2021-07-08
Who can join
Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
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).
Where it is running
- 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
Full record on ClinicalTrials.gov
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