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Kalifilcon A Toric Compared to Commercially Available Lenses

NCT ID: NCT06098937

Last Updated: 2024-12-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-05

Study Completion Date

2023-09-27

Brief Summary

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Approximately thirty contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), repeated measures insertion study.

Detailed Description

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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 study eligibility is met, subjects will have lenses inserted in random, successive order. Subjects will be receiving each of the study lens types once, in a randomized order. The subject will wear each of the study contact lenses for approximately 10 minutes.

Conditions

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Astigmatism

Keywords

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Contact Lens

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Kalifilcon A Daily Disposable Toric

Kalifilcon A Daily Disposable Toric

Group Type EXPERIMENTAL

Kalifilcon Toric Lens

Intervention Type DEVICE

Kalifilcon A Daily Disposable Toric for Ametropia

Total1 for Astigmatism

Total1 for Astigmatism

Group Type ACTIVE_COMPARATOR

Total1 for Astigmatism

Intervention Type DEVICE

Total1 for Astigmatism

Precision1 for Astigmatism

Precision1 for Astigmatism

Group Type ACTIVE_COMPARATOR

Precision1 for Astigmatism

Intervention Type DEVICE

Precision1 for Astigmatism

MyDay Toric

MyDay Toric

Group Type ACTIVE_COMPARATOR

MyDay Toric

Intervention Type DEVICE

MyDay Toric

Interventions

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Kalifilcon Toric Lens

Kalifilcon A Daily Disposable Toric for Ametropia

Intervention Type DEVICE

Total1 for Astigmatism

Total1 for Astigmatism

Intervention Type DEVICE

Precision1 for Astigmatism

Precision1 for Astigmatism

Intervention Type DEVICE

MyDay Toric

MyDay Toric

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bausch & Lomb, Incorporated

Rochester, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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ROC-23-007

Identifier Type: -

Identifier Source: org_study_id