AstigmatismNCT05129124

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

A study testing kalifilcon A Daily Disposable Toric LD213001 Contact Lenses and Commercially available Ultra for Astigmatism Contact Lenses in people with Astigmatism, run by Bausch & Lomb Incorporated at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Astigmatism
What is being tested?: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses and Commercially available Ultra for Astigmatism Contact Lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 30 Nov 2021to 13 Jan 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Bausch and Lomb Site 01
Rochester, New York, 14609

Other trials in United States

About this study

Conditions: Astigmatism
Being tested: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses, Commercially available Ultra for Astigmatism Contact Lenses
Medical subject headings: Astigmatism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

kalifilcon A Daily Disposable Toric LD213001 Contact LensesDevice
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
Commercially available Ultra for Astigmatism Contact LensesDevice
Commercially available Ultra for Astigmatism Contact Lenses at different fittings

Study groups in NCT05129124
Study group	Role	What they receive
T01: +6.00 -2.75 x 180	Experimental	kalifilcon A Daily Disposable Toric LD213001 Contact Lenses Receives: Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
T02: +6.00-2.75 x 090	Experimental	kalifilcon A Daily Disposable Toric LD213001 Contact Lenses Receives: Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
T03: -3.00-2.75 x180	Experimental	kalifilcon A Daily Disposable Toric LD213001 Contact Lenses Receives: Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
T04: -3.00 -2.75 x 090	Experimental	kalifilcon A Daily Disposable Toric LD213001 Contact Lenses Receives: Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
T05: -9.00 -2.75 x 180	Experimental	kalifilcon A Daily Disposable Toric LD213001 Contact Lenses Receives: Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
T06: -9.00 -2.75 x 090	Experimental	kalifilcon A Daily Disposable Toric LD213001 Contact Lenses Receives: Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
T07: -12.00 -2.75 x 180	Experimental	kalifilcon A Daily Disposable Toric LD213001 Contact Lenses Receives: Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
T08: -12.00-2.75 x 090	Experimental	kalifilcon A Daily Disposable Toric LD213001 Contact Lenses Receives: Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
C01: +6.00 -2.75 x 180	Active comparator	Commercially available Ultra for Astigmatism Contact Lenses Receives: Device: Commercially available Ultra for Astigmatism Contact Lenses
C02: +6.00-2.75 x 090	Active comparator	Commercially available Ultra for Astigmatism Contact Lenses Receives: Device: Commercially available Ultra for Astigmatism Contact Lenses
C03: -3.00-2.75 x180	Active comparator	Commercially available Ultra for Astigmatism Contact Lenses Receives: Device: Commercially available Ultra for Astigmatism Contact Lenses
C04: -3.00 -2.75 x 090	Active comparator	Commercially available Ultra for Astigmatism Contact Lenses Receives: Device: Commercially available Ultra for Astigmatism Contact Lenses
C05: -9.00 -2.75 x 180	Active comparator	Commercially available Ultra for Astigmatism Contact Lenses Receives: Device: Commercially available Ultra for Astigmatism Contact Lenses
C06: -9.00 -2.75 x 090	Active comparator	Commercially available Ultra for Astigmatism Contact Lenses Receives: Device: Commercially available Ultra for Astigmatism Contact Lenses

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees
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.
Measured: 3 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Nov 202113 Jan 2022

First posted22 Nov 2021
Study start30 Nov 2021
Primary completion13 Jan 2022
Study completion13 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AstigmatismStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05129124
Sponsor's protocol ID: 21-012
Status last verified: Jul 2025
First submitted: 10 Nov 2021
Last updated: 10 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
RecruitingPhase 4
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
Astigmatism
Recruiting
Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter
Myopia, Astigmatism
Active, not recruiting
Wavelight Plus Sightmap-LASIK vs. Wavefront-Optimized-LASIK
Myopia, Astigmatism

All Astigmatism trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Insertion Clinical Study to Evaluate the Orientation Characteristics of Multiple Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
ClinicalTrials.gov ID: NCT05129124
Acronym / sponsor ID: 21-012
Conditions: Astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: 30 Nov 2021 (actual)
Primary completion: 13 Jan 2022 (actual)
Study completion: 13 Jan 2022 (actual)
First posted: 22 Nov 2021 (actual)
Results: Posted 10 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 14

Arm	Type	Receives
T01: +6.00 -2.75 x 180	Experimental	Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenseskalifilcon A Daily Disposable Toric LD213001 Contact Lenses
T02: +6.00-2.75 x 090	Experimental	Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenseskalifilcon A Daily Disposable Toric LD213001 Contact Lenses
T03: -3.00-2.75 x180	Experimental	Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenseskalifilcon A Daily Disposable Toric LD213001 Contact Lenses
T04: -3.00 -2.75 x 090	Experimental	Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenseskalifilcon A Daily Disposable Toric LD213001 Contact Lenses
T05: -9.00 -2.75 x 180	Experimental	Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenseskalifilcon A Daily Disposable Toric LD213001 Contact Lenses
T06: -9.00 -2.75 x 090	Experimental	Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenseskalifilcon A Daily Disposable Toric LD213001 Contact Lenses
T07: -12.00 -2.75 x 180	Experimental	Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenseskalifilcon A Daily Disposable Toric LD213001 Contact Lenses
T08: -12.00-2.75 x 090	Experimental	Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenseskalifilcon A Daily Disposable Toric LD213001 Contact Lenses
C01: +6.00 -2.75 x 180	Active comparator	Device: Commercially available Ultra for Astigmatism Contact LensesCommercially available Ultra for Astigmatism Contact Lenses
C02: +6.00-2.75 x 090	Active comparator	Device: Commercially available Ultra for Astigmatism Contact LensesCommercially available Ultra for Astigmatism Contact Lenses
C03: -3.00-2.75 x180	Active comparator	Device: Commercially available Ultra for Astigmatism Contact LensesCommercially available Ultra for Astigmatism Contact Lenses
C04: -3.00 -2.75 x 090	Active comparator	Device: Commercially available Ultra for Astigmatism Contact LensesCommercially available Ultra for Astigmatism Contact Lenses
C05: -9.00 -2.75 x 180	Active comparator	Device: Commercially available Ultra for Astigmatism Contact LensesCommercially available Ultra for Astigmatism Contact Lenses
C06: -9.00 -2.75 x 090	Active comparator	Device: Commercially available Ultra for Astigmatism Contact LensesCommercially available Ultra for Astigmatism Contact Lenses

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
kalifilcon A Daily Disposable Toric LD213001 Contact Lenseskalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings	Device	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
Commercially available Ultra for Astigmatism Contact LensesCommercially available Ultra for Astigmatism Contact Lenses at different fittings	Device	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

Primary outcome

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.

Results and safety

Results posted to the registry on 10 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants Received Kalifilcon LD213001 Contact Lenses & Ultra for Astigmatism Contact Lenses	30	30

Primary outcome: Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees

Time frame: 3 minutes. Mean (Standard Deviation). Unit: degrees

Measure	All Participants Received Kalifilcon LD213001 ContactLenses and Ultra for Astigmatism Contact Lenses n = 30
T01	1.3 (3.92)
C01	3.3 (7.47)
T02	2.0 (4.47)
C02	3.0 (9.43)
T03	1.7 (3.79)
C03	4.0 (16.42)
T04	4.2 (13.90)
C04	1.3 (2.60)

Population analysed: Measurement Description: Lens orientation (in 5-degree increments) was measured in primary gaze (nasal = +, temporal = -)

Adverse events

Time frame: through study completion, an average of 40 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants Received Kalifilcon LD213001 ContactLenses and Ultra for Astigmatism Contact Lenses	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Astigmatism

Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
RecruitingPhase 4
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
Astigmatism
Recruiting
Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter
Myopia, Astigmatism
Active, not recruiting
Wavelight Plus Sightmap-LASIK vs. Wavefront-Optimized-LASIK
Myopia, Astigmatism

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeffery Schafer, OD principal investigator

Bausch & Lomb Incorporated

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees (time frame: 3 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05129124.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.