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

July 8, 2025 updated by: Bausch & Lomb Incorporated
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14609
        • Bausch and Lomb Site 01

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: T01: +6.00 -2.75 x 180
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
Experimental: T02: +6.00-2.75 x 090
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
Experimental: T03: -3.00-2.75 x180
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
Experimental: T04: -3.00 -2.75 x 090
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
Experimental: T05: -9.00 -2.75 x 180
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
Experimental: T06: -9.00 -2.75 x 090
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
Experimental: T07: -12.00 -2.75 x 180
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
Experimental: T08: -12.00-2.75 x 090
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
Active Comparator: C01: +6.00 -2.75 x 180
Commercially available Ultra for Astigmatism Contact Lenses
Device: Commercially available Ultra for Astigmatism Contact Lenses
Commercially available Ultra for Astigmatism Contact Lenses at different fittings
Active Comparator: C02: +6.00-2.75 x 090
Commercially available Ultra for Astigmatism Contact Lenses
Device: Commercially available Ultra for Astigmatism Contact Lenses
Commercially available Ultra for Astigmatism Contact Lenses at different fittings
Active Comparator: C03: -3.00-2.75 x180
Commercially available Ultra for Astigmatism Contact Lenses
Device: Commercially available Ultra for Astigmatism Contact Lenses
Commercially available Ultra for Astigmatism Contact Lenses at different fittings
Active Comparator: C04: -3.00 -2.75 x 090
Commercially available Ultra for Astigmatism Contact Lenses
Device: Commercially available Ultra for Astigmatism Contact Lenses
Commercially available Ultra for Astigmatism Contact Lenses at different fittings
Active Comparator: C05: -9.00 -2.75 x 180
Commercially available Ultra for Astigmatism Contact Lenses
Device: Commercially available Ultra for Astigmatism Contact Lenses
Commercially available Ultra for Astigmatism Contact Lenses at different fittings
Active Comparator: C06: -9.00 -2.75 x 090
Commercially available Ultra for Astigmatism Contact Lenses
Device: Commercially available Ultra for Astigmatism Contact Lenses
Commercially available Ultra for Astigmatism Contact Lenses at different fittings

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees
Time Frame: 3 minutes
Primary gaze orientation is measured in degrees. Measurement Description: Primary gaze is when the patient is looking straight ahead. Orientation refers to how much the contact lens is rotated on the eye. Primary gaze orientation of the contact lens is measured in degrees at the slit-lamp (microscope) using a reticle (protractor). Lens orientation was measured in primary gaze in 5-degree increments. Negative values indicate the contact lens was rotated in the temporal direction. Positive values indicate the contact lens was rotated in the nasal direction. The greater the value (positive or negative) the more the lens is rotated. The absolute value was calculated for all the measurements. The absolute values were used to calculate the mean primary gaze orientation after 3 minutes of contact lens wear. Criteria: P-values ≤0.05 will be considered statistically significant.
3 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bausch & Lomb Incorporated

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeffery Schafer, OD, Bausch & Lomb Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 13, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 13, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21-012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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