1-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Toric Contact Lenses Compared to Ultra for Astigmatism Contact Lenses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- Visual Acuity
Study Overview
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.
Detailed Description
Experienced toric soft contact lens wearers were enrolled and attended a Screening/Baseline visit (informed consent, eligibility, sphero-cylindrical baseline refraction). Participants were fit and dispensed either Test (kalifilcon A LD213001) or Comparator (Ultra for Astigmatism, samfilcon A) lenses in both eyes per a randomization schedule and wore them for ~1 week (7 ±3 days), ≥8 hours/day. Measurements (high-contrast logMAR visual acuity, visual quality, comfort, lens fit, and ocular health) were taken at the dispensing (insertion) visit and the 1-week follow-up visit. Participants then crossed over to the other lens type for a second ~1-week period. Continuous data were summarized with descriptive statistics; paired t-tests were used for parametric measures (p<0.05 significant). Non-inferiority margin for mean binocular logMAR VA was 0.06.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •Participating in a conflicting study.
- •Considered by the Investigator to not be a suitable candidate for participation.
Arms & Interventions
kalifilcon A Daily Disposable Toric (LD213001)
Participants wore kalifilcon A daily disposable toric (LD213001) lenses bilaterally as a daily disposable lens for ~1 week.
Intervention: kalifilcon A daily disposable toric contact lenses (Device)
Ultra for Astigmatism (samfilcon A)
Participants wore commercially available Ultra for Astigmatism (samfilcon A) lenses bilaterally in parameter-matched powers for ~1 week.
Intervention: Ultra for Astigmatism (samfilcon A) contact lenses (Device)
Outcomes
Primary Outcomes
Visual Acuity
Time Frame: One week
Mean Binocular logMAR Visual Acuity
Visual Acuity (logMAR)
Time Frame: One week (follow-up visit)
Mean Binocular logMAR Visual Acuity (High Contrast High Illumination; measured binocularly at 6 m).
Secondary Outcomes
No secondary outcomes reported