1-Week Dispensing Evaluation of Kalifilcon A Toric Contact Lenses Compared to Ultra for Astigmatism

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05320042
• Other study ID #: ROC2-21-013
• Status: Completed
• Phase: N/A
• Start date: February 14, 2022
• Est. completion date: May 10, 2022

Study information

• Verified date: November 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/Baseline Visit at which informed consent will be obtained and eligibility will be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 10, 2022
• Est. primary completion date: May 10, 2022
• 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 the 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.

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

Related Conditions & MeSH terms

• Astigmatism
• Myopia

Intervention

Device:
• kalifilcon A Daily Disposable Toric
kalifilcon A Daily Disposable Toric
• Ultra for Astigmatism Contact Lenses
Ultra for Astigmatism 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	One week