1-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Compared to Ultra for Presbyopia

Presbyopia Clinical Trial

Official title:

1-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Contact Lenses Compared to Ultra for Presbyopia Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05325931
• Other study ID #: ROC2-22-005
• Status: Completed
• Phase: N/A
• Start date: February 25, 2022
• Est. completion date: March 28, 2022

Study information

• Verified date: April 2022
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 28, 2022
• Est. primary completion date: March 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Participating in a conflicting study.

• Considered by the Investigator to not be a suitable candidate for participation.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• kalifilcon A Daily Disposable Multifocal
kalifilcon A Daily Disposable Multifocal low add and high
• samfilcon A for Presbyopia
Ultra for Presbyopia Low and High Add Contact Lenses

Locations

Country	Name	City	State
United States	Bausch site 1	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	Mean Binocular logMAR Visual Acuity at Distance (6m)	One week
Primary	Near Visual Acuity	Mean Binocular logMAR Visual Acuity at Near (40cm)	One week