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OpenTrials
Completed

NCT Number: NCT04840563

Surface Refractive Index Shift and Lens Absorption/Adsorption of Tear Components of Kalifilcon A Lenses vs Dailies Total1 and Precision1

Approximately 10 habitual soft contact lens wearing participants will be enrolled in this bilateral, randomized, double-masked (participant and investigator masked) repeated measures insertion study. All participants will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If participants satisfy all eligibility criteria and none of the exclusion criteria, participants will insert study lenses in random, successive order according to unique randomization schedules that will be provided to each Investigator.

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Key information

Conditions

Habitual Soft Contact Lens Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bausch Site 001

Rochester, New York, 14609, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be 18 years or older and have full legal capacity to volunteer.
  • 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

Kalifon A

Device

Commercially available kalifilcon A lenses

Dailies Total1

Device

Dailies Total1

Precision1

Device

Precision1

Primary outcomes

  1. Surface refractive index shifts

    Time frame: 10 minutes

    Immediately following lens removal, the right eye worn lenses for each subject will be measured for surface refractive index on the refractometer.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

Evaluation of Surface Refractive Index Shift and Lens Absorption / Adsorption of Tear Components of Commercially Available Kalifilcon A Lenses Compared to Dailies Total1 and Precision1

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 12, 2021
Registry last updated
Jul 22, 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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