Kalifilcon A Toric Compared to Commercially Available Lenses

Refractive Ametropia Clinical Trial

Official title:

Orientation Characteristics of Kalifilcon A Daily Disposable Toric Contact Lenses Compared to Commercially Available Daily Disposable Toric Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06098937
• Other study ID #: ROC-23-007
• Status: Completed
• Phase: N/A
• Start date: September 5, 2023
• Est. completion date: September 27, 2023

Study information

• Verified date: September 2023
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Approximately 30 soft toric contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), repeated measures insertion 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 have study lenses inserted in random, successive order according to unique randomization schedules that will be provided to each Investigator.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 27, 2023
• Est. primary completion date: September 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent.

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

• Refractive Ametropia
• Refractive Errors

Intervention

Device:
• Kalifilcon Toric Lens
Kalifilcon A Daily Disposable Toric for Ametropia
• Total1 for Astigmatism
Total1 for Astigmatism
• Precision1 for Astigmatism
Precision1 for Astigmatism
• MyDay Toric
MyDay Toric

Locations

Country	Name	City	State
United States	Bausch & Lomb, Incorporated	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	Primary gaze orientation for 5 minutes	Primary gaze orientation is measured in degrees using a slit lamp and reticule.	5 minutes after lens insertion