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Insertion Clinical Study to Evaluate the Aberration Characteristics of Kalifilcon A Toric Lenses

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Bausch + Lomb

Status

Completed

Conditions

Contact Lens Wearer

Treatments

Device: kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

This objective of this clinical study aims to confirm whether multiple kalifilcon A daily disposable toric contact lenses are providing the intended level of spherical aberration correction when worn.

Enrollment

75 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.
  3. A women of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the investigation if they meet any one of the following conditions: she is currently pregnant, she plans to become pregnant during the study, she is breastfeeding.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

75 participants in 1 patient group

kalifilcon A Daily Disposable Toric LD213001 lens
Experimental group
Description:
kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D
Treatment:
Device: kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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