Surface Refractive Index Shift and Lens Absorption/Adsorption of Tear Components of Kalifilcon A Lenses vs Dailies Total1 and Precision1

Habitual Soft Contact Lens Use Clinical Trial

Official title:

Evaluation of Surface Refractive Index Shift and Lens Absorption / Adsorption of Tear Components of Commercially Available Kalifilcon A Lenses Compared to Dailies Total1 and Precision1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04840563
• Other study ID #: ROC2-21-007
• Status: Completed
• Phase: N/A
• Start date: April 7, 2021
• Est. completion date: April 15, 2021

Study information

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

Clinical Trial Summary

Approximately 10 habitual soft contact lens wearing participants will be enrolled in this bilateral, 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, participants 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: April 15, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Be 18 years or older and have full legal capacity to volunteer.

2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.

3. Have no active ocular disease or allergic conjunctivitis.

4. Not be using any topical ocular medications.

5. Be willing and able to follow instructions.

6. Have signed a statement of informed consent.

Exclusion Criteria:

1. Participating in a conflicting study in the opinion of the Investigator.

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

Related Conditions & MeSH terms

• Habitual Soft Contact Lens Use

Intervention

Device:
• Kalifon A
Commercially available kalifilcon A lenses
• Dailies Total1
Dailies Total1
• Precision1
Precision1

Locations

Country	Name	City	State
United States	Bausch Site 001	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	Immediately following lens removal, the right eye worn lenses for each subject will be measured for surface refractive index on the refractometer.	10 minutes