Insertion Clinical Study to Evaluate the Orientation Characteristics of Multiple Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Study Overview
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Brief Summary
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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.

Official Title
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Insertion Clinical Study to Evaluate the Orientation Characteristics of Multiple Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Conditions
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Astigmatism

Intervention / Treatment
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* Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
* Device: Commercially available Ultra for Astigmatism Contact Lenses


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T01: +6.00 -2.75 x 180<br>kalifilcon A Daily Disposable Toric LD213001 Contact Lenses | Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses<br>* kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings<br>|
| Experimental: T02: +6.00-2.75 x 090<br>kalifilcon A Daily Disposable Toric LD213001 Contact Lenses | Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses<br>* kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings<br>|
| Experimental: T03: -3.00-2.75 x180<br>kalifilcon A Daily Disposable Toric LD213001 Contact Lenses | Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses<br>* kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings<br>|
| Experimental: T04: -3.00 -2.75 x 090<br>kalifilcon A Daily Disposable Toric LD213001 Contact Lenses | Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses<br>* kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings<br>|
| Experimental: T05: -9.00 -2.75 x 180<br>kalifilcon A Daily Disposable Toric LD213001 Contact Lenses | Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses<br>* kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings<br>|
| Experimental: T06: -9.00 -2.75 x 090<br>kalifilcon A Daily Disposable Toric LD213001 Contact Lenses | Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses<br>* kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings<br>|
| Experimental: T07: -12.00 -2.75 x 180<br>kalifilcon A Daily Disposable Toric LD213001 Contact Lenses | Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses<br>* kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings<br>|
| Experimental: T08: -12.00-2.75 x 090<br>kalifilcon A Daily Disposable Toric LD213001 Contact Lenses | Device: kalifilcon A Daily Disposable Toric LD213001 Contact Lenses<br>* kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings<br>|
| Active Comparator: C01: +6.00 -2.75 x 180<br>Commercially available Ultra for Astigmatism Contact Lenses | Device: Commercially available Ultra for Astigmatism Contact Lenses<br>* Commercially available Ultra for Astigmatism Contact Lenses at different fittings<br>|
| Active Comparator: C02: +6.00-2.75 x 090<br>Commercially available Ultra for Astigmatism Contact Lenses | Device: Commercially available Ultra for Astigmatism Contact Lenses<br>* Commercially available Ultra for Astigmatism Contact Lenses at different fittings<br>|
| Active Comparator: C03: -3.00-2.75 x180<br>Commercially available Ultra for Astigmatism Contact Lenses | Device: Commercially available Ultra for Astigmatism Contact Lenses<br>* Commercially available Ultra for Astigmatism Contact Lenses at different fittings<br>|
| Active Comparator: C04: -3.00 -2.75 x 090<br>Commercially available Ultra for Astigmatism Contact Lenses | Device: Commercially available Ultra for Astigmatism Contact Lenses<br>* Commercially available Ultra for Astigmatism Contact Lenses at different fittings<br>|
| Active Comparator: C05: -9.00 -2.75 x 180<br>Commercially available Ultra for Astigmatism Contact Lenses | Device: Commercially available Ultra for Astigmatism Contact Lenses<br>* Commercially available Ultra for Astigmatism Contact Lenses at different fittings<br>|
| Active Comparator: C06: -9.00 -2.75 x 090<br>Commercially available Ultra for Astigmatism Contact Lenses | Device: Commercially available Ultra for Astigmatism Contact Lenses<br>* Commercially available Ultra for Astigmatism Contact Lenses at different fittings<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Absolute Primary Gaze Orientation at 3 minutes for the lenses inserted at 90 degrees |  | 3 minutes |