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

NCT05320042 | Completed Results FDA Device

• 1 other identifier: ROC2-21-013
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This single-site, randomized, double-masked (participant and investigator), 2-way crossover, repeated-measures dispensing study evaluated the visual performance of kalifilcon A daily disposable toric (LD213001) contact lenses compared with commercially available Ultra for Astigmatism (samfilcon A) contact lenses in experienced soft contact lens wearers requiring astigmatic correction. Each participant wore both lens types as daily disposable lenses for approximately one week each, in a randomized order.

Conditions

Myopia; Astigmatism

Keywords

daily disposable; kalifilcon A; samfilcon A; astigmatism; contact lens; toric; Ultra

Outcome Measures

Primary Outcomes (1)

• Visual Acuity (logMAR)

  Mean Binocular logMAR Visual Acuity (High Contrast High Illumination; measured binocularly at 6 m).

  One week (follow-up visit)

Study Arms (2)

kalifilcon A Daily Disposable Toric (LD213001)

EXPERIMENTAL

Participants wore kalifilcon A daily disposable toric (LD213001) lenses bilaterally as a daily disposable lens for \~1 week.

Device: kalifilcon A daily disposable toric contact lenses

Ultra for Astigmatism (samfilcon A)

ACTIVE COMPARATOR

Participants wore commercially available Ultra for Astigmatism (samfilcon A) lenses bilaterally in parameter-matched powers for \~1 week.

Device: Ultra for Astigmatism (samfilcon A) contact lenses

Interventions

kalifilcon A daily disposable toric contact lenses DEVICE

kalifilcon A daily disposable toric contact lens (LD213001) - hydrophilic siloxane copolymer, 55% water, UV-absorbing, blue visibility tint; multiple powers.

kalifilcon A Daily Disposable Toric (LD213001)

Ultra for Astigmatism (samfilcon A) contact lenses DEVICE

Device: Ultra for Astigmatism (samfilcon A) contact lens - commercially available, parameter-matched powers.

Also known as: Ultra for Astigmatism

Ultra for Astigmatism (samfilcon A)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch site 1

Rochester, New York, 14609, United States

Location

MeSH Terms

Conditions

Myopia; Astigmatism

Interventions

Contact Lenses

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Limitations and Caveats

The study was conducted at one site.

Results Point of Contact

• Title: Jeffery Schafer, Director Clinical Research
• Organization: Bausch + Lomb

jeffery.schafer@bausch.com

5856032402

Study Officials

• Jeffery Schafer

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2-way, 2-period crossover; each participant wore both lens types (Test and Comparator) in a randomized order, \~1 week each.

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 11, 2022
• Study Start: February 14, 2022
• Primary Completion: May 10, 2022
• Study Completion: May 10, 2022
• Last Updated: September 17, 2026
• Results First Posted: September 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)