Insertion Clinical Study to Evaluate the Orientation Characteristics of Multiple Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

NCT ID: NCT05129124

Last Updated: 2025-07-10

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-30

Study Completion Date

2022-01-13

Brief Summary

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The objective is to evaluate the fit characteristics (primary gaze orientation, rotational recovery, and movement) of kalifilcon A daily disposable toric lenses as compared to commercially available Ultra for Astigmatism lenses.

Detailed Description

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Conditions

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Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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T01: +6.00 -2.75 x 180

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Group Type EXPERIMENTAL

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Intervention Type DEVICE

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings

T02: +6.00-2.75 x 090

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Group Type EXPERIMENTAL

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Intervention Type DEVICE

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings

T03: -3.00-2.75 x180

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Group Type EXPERIMENTAL

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Intervention Type DEVICE

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings

T04: -3.00 -2.75 x 090

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Group Type EXPERIMENTAL

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Intervention Type DEVICE

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings

T05: -9.00 -2.75 x 180

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Group Type EXPERIMENTAL

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Intervention Type DEVICE

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings

T06: -9.00 -2.75 x 090

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Group Type EXPERIMENTAL

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Intervention Type DEVICE

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings

T07: -12.00 -2.75 x 180

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Group Type EXPERIMENTAL

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Intervention Type DEVICE

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings

T08: -12.00-2.75 x 090

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Group Type EXPERIMENTAL

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Intervention Type DEVICE

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings

C01: +6.00 -2.75 x 180

Commercially available Ultra for Astigmatism Contact Lenses

Group Type ACTIVE_COMPARATOR

Commercially available Ultra for Astigmatism Contact Lenses

Intervention Type DEVICE

Commercially available Ultra for Astigmatism Contact Lenses at different fittings

C02: +6.00-2.75 x 090

Commercially available Ultra for Astigmatism Contact Lenses

Group Type ACTIVE_COMPARATOR

Commercially available Ultra for Astigmatism Contact Lenses

Intervention Type DEVICE

Commercially available Ultra for Astigmatism Contact Lenses at different fittings

C03: -3.00-2.75 x180

Commercially available Ultra for Astigmatism Contact Lenses

Group Type ACTIVE_COMPARATOR

Commercially available Ultra for Astigmatism Contact Lenses

Intervention Type DEVICE

Commercially available Ultra for Astigmatism Contact Lenses at different fittings

C04: -3.00 -2.75 x 090

Commercially available Ultra for Astigmatism Contact Lenses

Group Type ACTIVE_COMPARATOR

Commercially available Ultra for Astigmatism Contact Lenses

Intervention Type DEVICE

Commercially available Ultra for Astigmatism Contact Lenses at different fittings

C05: -9.00 -2.75 x 180

Commercially available Ultra for Astigmatism Contact Lenses

Group Type ACTIVE_COMPARATOR

Commercially available Ultra for Astigmatism Contact Lenses

Intervention Type DEVICE

Commercially available Ultra for Astigmatism Contact Lenses at different fittings

C06: -9.00 -2.75 x 090

Commercially available Ultra for Astigmatism Contact Lenses

Group Type ACTIVE_COMPARATOR

Commercially available Ultra for Astigmatism Contact Lenses

Intervention Type DEVICE

Commercially available Ultra for Astigmatism Contact Lenses at different fittings

Interventions

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kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings

Intervention Type DEVICE

Commercially available Ultra for Astigmatism Contact Lenses

Commercially available Ultra for Astigmatism Contact Lenses at different fittings

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.
2. Considered by the Investigator to not be a suitable candidate for participation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffery Schafer, OD

Role: PRINCIPAL_INVESTIGATOR

Bausch & Lomb Incorporated

Locations

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Bausch and Lomb Site 01

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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21-012

Identifier Type: -

Identifier Source: org_study_id

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