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NCT05129072

Insertion Clinical Study to Evaluate the Aberration Characteristics of Kalifilcon A Toric Lenses

Completed NA Results posted Last updated 24 June 2025
What this trial tests

NA trial testing kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D in Contact Lens Wearer in 75 participants. Completed in 24 September 2021.

Timeline
25 August 2021
Primary endpoint
24 September 2021
24 September 2021

Quick facts

Lead sponsorBausch & Lomb Incorporated
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment75
Start date25 August 2021
Primary completion24 September 2021
Estimated completion24 September 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Bausch & Lomb Incorporated — full company profile →

Who can join

18 and older, any sex, with Contact Lens Wearer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Spherical Aberration Measurement Primary · 60 minutes

Spherical aberration (SA) occurs when light rays entering at different points of a spherical lens are not focused to the same point of the optical axis.

T01 (kali +6D)
GroupValue95% CI
Spherical Aberration of Kalifilcon A Daily Disposable Toric LD213001 Lens0.162± 0.187
T02 (kali +3D)
GroupValue95% CI
Spherical Aberration of Kalifilcon A Daily Disposable Toric LD213001 Lens0.090± 0.120
T03 (kali 0D)
GroupValue95% CI
Spherical Aberration of Kalifilcon A Daily Disposable Toric LD213001 Lens0.017± 0.133
T04 (kali -3D)
GroupValue95% CI
Spherical Aberration of Kalifilcon A Daily Disposable Toric LD213001 Lens0.052± 0.145
T05 (kali -6D)
GroupValue95% CI
Spherical Aberration of Kalifilcon A Daily Disposable Toric LD213001 Lens0.062± 0.158
T06 (kali -9D)
GroupValue95% CI
Spherical Aberration of Kalifilcon A Daily Disposable Toric LD213001 Lens0.102± 0.164
Visibility of Toric Etch Mark by the Investigator Secondary · 60 minutes

Number of lenses the investigator could identify the toric etch mark

T01 kali +6D
GroupValue95% CI
Kalifilcon A Daily Disposable Toric Etch Mark Visibility26
T02 kali +3D
GroupValue95% CI
Kalifilcon A Daily Disposable Toric Etch Mark Visibility30
T03 kali +0D
GroupValue95% CI
Kalifilcon A Daily Disposable Toric Etch Mark Visibility30
T04 kali -3D
GroupValue95% CI
Kalifilcon A Daily Disposable Toric Etch Mark Visibility30
T05 kali -6D
GroupValue95% CI
Kalifilcon A Daily Disposable Toric Etch Mark Visibility30
T06 kali -9D
GroupValue95% CI
Kalifilcon A Daily Disposable Toric Etch Mark Visibility30

Sponsor's own description

This objective of this clinical study aims to confirm whether multiple kalifilcon A daily disposable toric contact lenses are providing the intended level of spherical aberration correction when worn.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other Bausch & Lomb Incorporated trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05129072.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing