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Kalifilcon A Toric Compared to Commercially Available Lenses

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Bausch + Lomb

Status

Completed

Conditions

Refractive Ametropia

Treatments

Device: MyDay Toric
Device: Kalifilcon Toric Lens
Device: Total1 for Astigmatism
Device: Precision1 for Astigmatism

Study type

Interventional

Funder types

Industry

Identifiers

NCT06098937
ROC-23-007

Details and patient eligibility

About

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 subjects satisfy all eligibility criteria and none of the exclusion criteria, subjects will have study lenses inserted in random, successive order according to unique randomization schedules that will be provided to each Investigator.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. 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.
  2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
  3. Have no active ocular disease or allergic conjunctivitis.
  4. Not be using any topical ocular medications.
  5. Be willing and able to follow instructions.
  6. Have signed a statement of informed consent.

Exclusion criteria

  1. Participating in a conflicting study in the opinion of the Investigator.
  2. 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

30 participants in 4 patient groups

Kalifilcon A Daily Disposable Toric
Experimental group
Description:
Kalifilcon A Daily Disposable Toric
Treatment:
Device: Kalifilcon Toric Lens
Total1 for Astigmatism
Active Comparator group
Description:
Total1 for Astigmatism
Treatment:
Device: Total1 for Astigmatism
Precision1 for Astigmatism
Active Comparator group
Description:
Precision1 for Astigmatism
Treatment:
Device: Precision1 for Astigmatism
MyDay Toric
Active Comparator group
Description:
MyDay Toric
Treatment:
Device: MyDay Toric

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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