Insertion Clinical Study to Evaluate the Orientation Characteristics of Multiple Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
Status
Completed
Conditions
Astigmatism
Treatments
Device: Commercially available Ultra for Astigmatism Contact Lenses
Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
Details and patient eligibility
About
The objective is to evaluate the fit characteristics (primary gaze orientation, rotational recovery, and movement) of kalifilcon A daily disposable toric lenses as compared to commercially available Ultra for Astigmatism lenses.
Enrollment
30 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- 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.
- 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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
30 participants in 14 patient groups
T01: +6.00 -2.75 x 180
Experimental group
Description:
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
Treatment:
Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
T02: +6.00-2.75 x 090
Experimental group
Description:
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
Treatment:
Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
T03: -3.00-2.75 x180
Experimental group
Description:
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
Treatment:
Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
T04: -3.00 -2.75 x 090
Experimental group
Description:
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
Treatment:
Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
T05: -9.00 -2.75 x 180
Experimental group
Description:
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
Treatment:
Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
T06: -9.00 -2.75 x 090
Experimental group
Description:
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
Treatment:
Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
T07: -12.00 -2.75 x 180
Experimental group
Description:
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
Treatment:
Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
T08: -12.00-2.75 x 090
Experimental group
Description:
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
Treatment:
Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
C01: +6.00 -2.75 x 180
Active Comparator group
Description:
Commercially available Ultra for Astigmatism Contact Lenses
Treatment:
Device: Commercially available Ultra for Astigmatism Contact Lenses
C02: +6.00-2.75 x 090
Active Comparator group
Description:
Commercially available Ultra for Astigmatism Contact Lenses
Treatment:
Device: Commercially available Ultra for Astigmatism Contact Lenses
C03: -3.00-2.75 x180
Active Comparator group
Description:
Commercially available Ultra for Astigmatism Contact Lenses
Treatment:
Device: Commercially available Ultra for Astigmatism Contact Lenses
C04: -3.00 -2.75 x 090
Active Comparator group
Description:
Commercially available Ultra for Astigmatism Contact Lenses
Treatment:
Device: Commercially available Ultra for Astigmatism Contact Lenses
C05: -9.00 -2.75 x 180
Active Comparator group
Description:
Commercially available Ultra for Astigmatism Contact Lenses
Treatment:
Device: Commercially available Ultra for Astigmatism Contact Lenses
C06: -9.00 -2.75 x 090
Active Comparator group
Description:
Commercially available Ultra for Astigmatism Contact Lenses
Treatment:
Device: Commercially available Ultra for Astigmatism Contact Lenses
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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