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

Primary Purpose

Astigmatism

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Commercially available Ultra for Astigmatism Contact Lenses

About this trial

This is an interventional treatment trial for Astigmatism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Participating in a conflicting study.
Considered by the Investigator to not be a suitable candidate for participation.

Sites / Locations

Bausch and Lomb Site 01

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm Type

Experimental

Active Comparator

Arm Label

T01: +6.00 -2.75 x 180

T02: +6.00-2.75 x 090

T03: -3.00-2.75 x180

T04: -3.00 -2.75 x 090

T05: -9.00 -2.75 x 180

T06: -9.00 -2.75 x 090

T07: -12.00 -2.75 x 180

T08: -12.00-2.75 x 090

C01: +6.00 -2.75 x 180

C02: +6.00-2.75 x 090

C03: -3.00-2.75 x180

C04: -3.00 -2.75 x 090

C05: -9.00 -2.75 x 180

C06: -9.00 -2.75 x 090

Arm Description

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Commercially available Ultra for Astigmatism Contact Lenses

Outcomes

Primary Outcome Measures

Mean Absolute Primary Gaze Orientation at 3 minutes for the lenses inserted at 90 degrees

Secondary Outcome Measures

Full Information

NCT ID

NCT05129124

First Posted

November 10, 2021

Last Updated

March 28, 2022

Sponsor

Bausch & Lomb Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT05129124

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

November 30, 2021 (Actual)

Primary Completion Date

January 13, 2022 (Actual)

Study Completion Date

January 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bausch & Lomb Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Astigmatism

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

T01: +6.00 -2.75 x 180

Arm Type

Experimental

Arm Description

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Arm Title

T02: +6.00-2.75 x 090

Arm Type

Experimental

Arm Description

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Arm Title

T03: -3.00-2.75 x180

Arm Type

Experimental

Arm Description

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Arm Title

T04: -3.00 -2.75 x 090

Arm Type

Experimental

Arm Description

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Arm Title

T05: -9.00 -2.75 x 180

Arm Type

Experimental

Arm Description

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Arm Title

T06: -9.00 -2.75 x 090

Arm Type

Experimental

Arm Description

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Arm Title

T07: -12.00 -2.75 x 180

Arm Type

Experimental

Arm Description

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Arm Title

T08: -12.00-2.75 x 090

Arm Type

Experimental

Arm Description

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Arm Title

C01: +6.00 -2.75 x 180

Arm Type

Active Comparator

Arm Description

Commercially available Ultra for Astigmatism Contact Lenses

Arm Title

C02: +6.00-2.75 x 090

Arm Type

Active Comparator

Arm Description

Commercially available Ultra for Astigmatism Contact Lenses

Arm Title

C03: -3.00-2.75 x180

Arm Type

Active Comparator

Arm Description

Commercially available Ultra for Astigmatism Contact Lenses

Arm Title

C04: -3.00 -2.75 x 090

Arm Type

Active Comparator

Arm Description

Commercially available Ultra for Astigmatism Contact Lenses

Arm Title

C05: -9.00 -2.75 x 180

Arm Type

Active Comparator

Arm Description

Commercially available Ultra for Astigmatism Contact Lenses

Arm Title

C06: -9.00 -2.75 x 090

Arm Type

Active Comparator

Arm Description

Commercially available Ultra for Astigmatism Contact Lenses

Intervention Type

Device

Intervention Name(s)

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Intervention Description

kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings

Intervention Type

Device

Intervention Name(s)

Commercially available Ultra for Astigmatism Contact Lenses

Intervention Description

Commercially available Ultra for Astigmatism Contact Lenses at different fittings

Primary Outcome Measure Information:

Title

Mean Absolute Primary Gaze Orientation at 3 minutes for the lenses inserted at 90 degrees

Time Frame

3 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. Have no active ocular disease or allergic conjunctivitis. Not be using any topical ocular medications. Be willing and able to follow instructions. Have signed a statement of informed consent. Exclusion Criteria: Participating in a conflicting study. Considered by the Investigator to not be a suitable candidate for participation.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffery Schafer, OD

Organizational Affiliation

Bausch & Lomb Incorporated

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bausch and Lomb Site 01

City

Rochester

State/Province

New York

ZIP/Postal Code

14609

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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