Insertion Clinical Study to Evaluate the Aberration Characteristics of Kalifilcon A Toric Lenses
1 other identifier
interventional
75
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 24, 2021
CompletedFirst Submitted
Initial submission to the registry
November 10, 2021
CompletedFirst Posted
Study publicly available on registry
November 22, 2021
CompletedResults Posted
Study results publicly available
June 24, 2025
CompletedJune 24, 2025
June 1, 2025
1 month
November 10, 2021
February 9, 2023
June 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Spherical Aberration Measurement
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.
60 minutes
Secondary Outcomes (1)
Visibility of Toric Etch Mark by the Investigator
60 minutes
Study Arms (1)
kalifilcon A Daily Disposable Toric LD213001 lens
EXPERIMENTALkalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D
Interventions
kalifilcon A Daily Disposable Toric LD213001 lens
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bausch and Lomb Site 01
Rochester, New York, 14609, United States
Results Point of Contact
- Title
- Steffen Robert, Senior Director Clinical Affairs
- Organization
- Bausch + Lomb Incorporated
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffery Schafer, OD
Bausch & Lomb Incorporated
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2021
First Posted
November 22, 2021
Study Start
August 25, 2021
Primary Completion
September 24, 2021
Study Completion
September 24, 2021
Last Updated
June 24, 2025
Results First Posted
June 24, 2025
Record last verified: 2025-06