1-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Compared to Ultra for Presbyopia
1 other identifier
interventional
30
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/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If subjects satisfy all eligibility criteria and none of the exclusion criteria, subjects will be fit and dispensed study lenses according to unique randomization schedules that will be provided to each Investigator If vision is unsatisfactory in the original dispensed lenses, additional lens powers may be trialed.
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 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2022
CompletedFirst Submitted
Initial submission to the registry
April 1, 2022
CompletedFirst Posted
Study publicly available on registry
April 13, 2022
CompletedApril 13, 2022
April 1, 2022
1 month
April 1, 2022
April 12, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Visual Acuity
Mean Binocular logMAR Visual Acuity at Distance (6m)
One week
Near Visual Acuity
Mean Binocular logMAR Visual Acuity at Near (40cm)
One week
Study Arms (2)
kalifilcon A Daily Disposable Multifocal
EXPERIMENTALkalifilcon A Daily Disposable Multifocal Low Add Power (LA) and High Add Power (HA)
samfilcon A for Presbyopia
ACTIVE COMPARATORB+L ULTRA for Presbyopia Low Add Power (LA) and High Add Power (HA)
Interventions
kalifilcon A Daily Disposable Multifocal low add and high
Ultra for Presbyopia Low and High Add Contact Lenses
Eligibility Criteria
You may qualify if:
- Be 40 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, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2022
First Posted
April 13, 2022
Study Start
February 25, 2022
Primary Completion
March 28, 2022
Study Completion
March 28, 2022
Last Updated
April 13, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share