Insertion Clinical Study to Evaluate the Orientation Characteristics of Multiple Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 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
First Submitted
Initial submission to the registry
November 10, 2021
CompletedFirst Posted
Study publicly available on registry
November 22, 2021
CompletedStudy Start
First participant enrolled
November 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2022
CompletedResults Posted
Study results publicly available
July 10, 2025
CompletedJuly 10, 2025
July 1, 2025
1 month
November 10, 2021
August 31, 2023
July 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
3 minutes
Study Arms (14)
T01: +6.00 -2.75 x 180
EXPERIMENTALkalifilcon A Daily Disposable Toric LD213001 Contact Lenses
T02: +6.00-2.75 x 090
EXPERIMENTALkalifilcon A Daily Disposable Toric LD213001 Contact Lenses
T03: -3.00-2.75 x180
EXPERIMENTALkalifilcon A Daily Disposable Toric LD213001 Contact Lenses
T04: -3.00 -2.75 x 090
EXPERIMENTALkalifilcon A Daily Disposable Toric LD213001 Contact Lenses
T05: -9.00 -2.75 x 180
EXPERIMENTALkalifilcon A Daily Disposable Toric LD213001 Contact Lenses
T06: -9.00 -2.75 x 090
EXPERIMENTALkalifilcon A Daily Disposable Toric LD213001 Contact Lenses
T07: -12.00 -2.75 x 180
EXPERIMENTALkalifilcon A Daily Disposable Toric LD213001 Contact Lenses
T08: -12.00-2.75 x 090
EXPERIMENTALkalifilcon A Daily Disposable Toric LD213001 Contact Lenses
C01: +6.00 -2.75 x 180
ACTIVE COMPARATORCommercially available Ultra for Astigmatism Contact Lenses
C02: +6.00-2.75 x 090
ACTIVE COMPARATORCommercially available Ultra for Astigmatism Contact Lenses
C03: -3.00-2.75 x180
ACTIVE COMPARATORCommercially available Ultra for Astigmatism Contact Lenses
C04: -3.00 -2.75 x 090
ACTIVE COMPARATORCommercially available Ultra for Astigmatism Contact Lenses
C05: -9.00 -2.75 x 180
ACTIVE COMPARATORCommercially available Ultra for Astigmatism Contact Lenses
C06: -9.00 -2.75 x 090
ACTIVE COMPARATORCommercially available Ultra for Astigmatism Contact Lenses
Interventions
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
Commercially available Ultra for Astigmatism Contact Lenses at different fittings
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.
- Considered by the Investigator to not be a suitable candidate for participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bausch and Lomb Site 01
Rochester, New York, 14609, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jill Schafer
- Organization
- Bausch + Lomb Incorporated
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffery Schafer, OD
Bausch & Lomb Incorporated
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2021
First Posted
November 22, 2021
Study Start
November 30, 2021
Primary Completion
January 13, 2022
Study Completion
January 13, 2022
Last Updated
July 10, 2025
Results First Posted
July 10, 2025
Record last verified: 2025-07