Evaluation of Surface Refractive Index Shift of Kalifilcon A Lenses Compared to Dailies Total 1, Precision 1 and Biotrue ONEday Lenses

Habitual Soft Contact Lens Use Clinical Trial

Official title:

Evaluation of Surface Refractive Index Shift of Kalifilcon A Lenses Compared to Dailies Total 1, Precision 1 and Biotrue ONEday Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04555031
• Other study ID #: ROC2-20-012
• Status: Completed
• Phase: N/A
• Start date: September 9, 2020
• Est. completion date: September 16, 2020

Study information

• Verified date: October 2021
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Approximately 20 habitual soft contact lens wearing participants will be enrolled in this unilateral, randomized, double-masked (participant and investigator masked) repeated measures insertion study. All participants will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If participants satisfy all eligibility criteria and none of the exclusion criteria, subjects will insert study lenses in random, successive order according to unique randomization schedules that will be provided to each Investigator.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 16, 2020
• Est. primary completion date: September 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older and have full legal capacity to volunteer.
• Physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
• No active ocular disease or allergic conjunctivitis.
• Not using any topical ocular medications.
• Willing and able to follow instructions.
• Signed a statement of informed consent.

Exclusion Criteria:

• Participating in a conflicting study in the opinion of the Investigator.
• Considered by the Investigator to not be a suitable candidate for participation.

Related Conditions & MeSH terms

• Habitual Soft Contact Lens Use

Intervention

Device:
• kalifilcon A lenses
Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.
• Dalies Total 1
Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.
• Precision 1
Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.
• Biotrue ONEday
Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.

Locations

Country	Name	City	State
United States	Bausch and Lomb Site 01	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	Surface Refractive Index Shifts at 5 Minutes	Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units.	5 minutes
Primary	Surface Refractive Index Shifts at 10 Minutes	Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units.	10 minutes
Primary	Surface Refractive Index Shifts at 15 Minutes	Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units.	15 minutes