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OpenTrials
Completed

NCT Number: NCT04555031

Evaluation of Surface Refractive Index Shift of Kalifilcon A Lenses Compared to Dailies Total 1, Precision 1 and Biotrue ONEday Lenses

Approximately 20 habitual soft contact lens wearing participants will be enrolled in this unilateral, 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, subjects 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 and Lomb Site 01

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

  • 18 years or older and have full legal capacity to volunteer.
  • Physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
  • No active ocular disease or allergic conjunctivitis.
  • Not using any topical ocular medications.
  • Willing and able to follow instructions.
  • 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 A lenses

Device

Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.

Dalies Total 1

Device

Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.

Precision 1

Device

Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.

Biotrue ONEday

Device

Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.

Primary outcomes

  1. Surface Refractive Index Shifts at 5 Minutes

    Time frame: 5 minutes

    Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units.

  2. Surface Refractive Index Shifts at 10 Minutes

    Time frame: 10 minutes

    Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units.

  3. Surface Refractive Index Shifts at 15 Minutes

    Time frame: 15 minutes

    Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 18, 2020
Registry last updated
Nov 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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