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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-25

Study Completion Date

2021-09-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Contact Lens Wearer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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kalifilcon A Daily Disposable Toric LD213001 lens

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

kalifilcon A Daily Disposable Toric LD213001 lens

Interventions

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

kalifilcon A Daily Disposable Toric LD213001 lens

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No