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

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Bausch + Lomb

Status

Completed

Conditions

Habitual Soft Contact Lens Use

Treatments

Device: Dalies Total 1
Device: Precision 1
Device: kalifilcon A lenses
Device: Biotrue ONEday

Study type

Interventional

Funder types

Industry

Identifiers

NCT04555031
ROC2-20-012

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

10 participants in 4 patient groups

kalifilcon A lenses
Experimental group
Treatment:
Device: kalifilcon A lenses
Dailies Total 1
Active Comparator group
Treatment:
Device: Dalies Total 1
Precision 1
Active Comparator group
Treatment:
Device: Precision 1
Biotrue ONEday
Active Comparator group
Treatment:
Device: Biotrue ONEday

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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