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OpenTrials
Completed

NCT Number: NCT04901897

Product Performance of a New Silicone Hydrogel Contact Lens

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bausch Site 433, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

kalifilcon A

Device

kalifilcon A daily disposable contact lens

delefilcon A

Device

DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses

Senofilcon A

Device

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

Primary outcomes

  1. Mean Change in logMAR Contact Lens Visual Acuity

    Time frame: Baseline, 2 Week Follow up

    logMAR is the logarithm of the minim angle of resolution

  2. Percentage of Participants in the Test Lens Group Agreeing With the Statement "Are Comfortable Throughout the Day"

    Time frame: 2 Week Follow up

  3. Percentage of Participants in the Test Lens Group Agreeing With the Statement "Provide Clear Vision Throughout the Day"

    Time frame: 2 Week Follow up

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 26, 2021
Registry last updated
Jul 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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