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OpenTrials
Completed

NCT Number: NCT06098937

Kalifilcon A Toric Compared to Commercially Available Lenses

Approximately thirty contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), repeated measures insertion study.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bausch & Lomb, Incorporated

Rochester, New York, 14609, United States

About this study

Approximately 30 soft toric contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), repeated measures insertion study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If study eligibility is met, subjects will have lenses inserted in random, successive order. Subjects will be receiving each of the study lens types once, in a randomized order. The subject will wear each of the study contact lenses for approximately 10 minutes.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent.
  • Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
  • Have no active ocular disease or allergic conjunctivitis.
  • Not be using any topical ocular medications.
  • Be willing and able to follow instructions.
  • Have signed a statement of informed consent.

Exclusion criteria

  • Participating in a conflicting study in the opinion of the Investigator.
  • Considered by the Investigator to not be a suitable candidate for participation

Treatment and study plan

Kalifilcon Toric Lens

Device

Kalifilcon A Daily Disposable Toric for Ametropia

Total1 for Astigmatism

Device

Total1 for Astigmatism

Precision1 for Astigmatism

Device

Precision1 for Astigmatism

MyDay Toric

Device

MyDay Toric

Primary outcomes

  1. Primary Gaze Orientation for 5 Minutes

    Time frame: 5 minutes after lens insertion

    Primary gaze orientation is measured in degrees using a slit lamp and reticule.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

Orientation Characteristics of Kalifilcon A Daily Disposable Toric Contact Lenses Compared to Commercially Available Daily Disposable Toric Contact Lenses

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 25, 2023
Registry last updated
Dec 10, 2024

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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