Kalifilcon A Toric Compared to Commercially Available Lenses
Orientation Characteristics of Kalifilcon A Daily Disposable Toric Contact Lenses Compared to Commercially Available Daily Disposable Toric Contact Lenses
1 other identifier
interventional
30
1 country
1
Brief Summary
Approximately thirty contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), repeated measures insertion study.
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 Sep 2023
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
September 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 27, 2023
CompletedFirst Submitted
Initial submission to the registry
September 29, 2023
CompletedFirst Posted
Study publicly available on registry
October 25, 2023
CompletedResults Posted
Study results publicly available
December 10, 2024
CompletedDecember 10, 2024
December 1, 2024
22 days
September 29, 2023
October 1, 2024
December 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Gaze Orientation for 5 Minutes
Primary gaze orientation is measured in degrees using a slit lamp and reticule.
5 minutes after lens insertion
Study Arms (4)
Kalifilcon A Daily Disposable Toric
EXPERIMENTALKalifilcon A Daily Disposable Toric
Total1 for Astigmatism
ACTIVE COMPARATORTotal1 for Astigmatism
Precision1 for Astigmatism
ACTIVE COMPARATORPrecision1 for Astigmatism
MyDay Toric
ACTIVE COMPARATORMyDay Toric
Interventions
Kalifilcon A Daily Disposable Toric for Ametropia
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bausch & Lomb, Incorporated
Rochester, New York, 14609, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jeffery Schafer, OD, MS Director, Clinical Research
- Organization
- Bausch & Lomb
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2023
First Posted
October 25, 2023
Study Start
September 5, 2023
Primary Completion
September 27, 2023
Study Completion
September 27, 2023
Last Updated
December 10, 2024
Results First Posted
December 10, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share