1-Week Dispensing Evaluation of Kalifilcon A Toric Contact Lenses Compared to Ultra for Astigmatism
1 other identifier
interventional
28
1 country
1
Brief Summary
Experienced soft contact lens wearing subjects will be enrolled in this 1-week, confirmatory, randomized, bilateral, 2-way crossover, double masked (subject and investigator), repeated measures, dispensing study. All subjects will be seen for a Screening/Baseline Visit at which informed consent will be obtained and eligibility will be assessed.
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 Feb 2022
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
February 14, 2022
CompletedFirst Submitted
Initial submission to the registry
April 1, 2022
CompletedFirst Posted
Study publicly available on registry
April 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2022
CompletedNovember 17, 2022
November 1, 2022
3 months
April 1, 2022
November 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Visual Acuity
Mean Binocular logMAR Visual Acuity
One week
Study Arms (2)
kalifilcon A Daily Disposable Toric
EXPERIMENTALkalifilcon A Daily Disposable Toric
Ultra for Astigmatism Contact Lenses
ACTIVE COMPARATORUltra for Astigmatism Contact Lenses
Interventions
kalifilcon A Daily Disposable Toric
Ultra for Astigmatism Contact Lenses
Eligibility Criteria
You may qualify if:
- Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have the 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 site 1
Rochester, New York, 14609, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert Steffen
Bausch & Lomb Incorporated
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2022
First Posted
April 11, 2022
Study Start
February 14, 2022
Primary Completion
May 10, 2022
Study Completion
May 10, 2022
Last Updated
November 17, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share