N/A
N=75
Insertion Clinical Study to Evaluate the Aberration Characteristics of Kalifilcon A Toric Lenses
Contact Lens Wearer
Bottom Line
View on ClinicalTrials.gov: NCT05129072 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Spherical Aberration Measurement — 0.162; 0.090; 0.017; 0.052 microns
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Spherical Aberration Measurement |
0.162; 0.090; 0.017; 0.052; 0.062; 0.102 | — |
| SECONDARY Visibility of Toric Etch Mark by the Investigator |
26; 30; 30; 30; 30; 30 | — |
Summary
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.
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 in the opinion of the Investigator.
- Considered by the Investigator to not be a suitable candidate for participation.
- A women of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the investigation if they meet any one of the following conditions: she is currently pregnant, she plans to become pregnant during the study, she is breastfeeding.
Data sourced from ClinicalTrials.gov (NCT05129072). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.