On-Eye Evaluation of Contact Lens Axis Location

Study Overview
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Brief Summary
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The purpose of this study was to evaluate the axis location of toric contact lenses after 3 minutes of wear. During this 1-visit study, each participant wore 3 pairs of study lenses of various design iterations (2-87-1, 2-87-2, 2-87-3) for an exposure time of approximately 30 minutes each. Each pair consisted of lenses of the same design iteration, 1 lens with embossed mark [TEST1 (T1), TEST3 (T3), TEST5 (T5)], worn on the right eye, and 1 lens without embossed mark [TEST2 (T2), TEST4 (T4), and TEST6 (T6)] worn on the left eye.

Conditions
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Myopia, Astigmatism, Refractive Error

Intervention / Treatment
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* Device: Delefilcon A toric contact lens T1
* Device: Delefilcon A toric contact lens T2
* Device: Delefilcon A toric contact lens T3
* Device: Delefilcon A toric contact lens T4
* Device: Delefilcon A toric contact lens T5
* Device: Delefilcon A toric contact lens T6


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign written Informed Consent. Best corrected distance visual acuity greater than or equal to 20/25 in each eye. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: History of any ocular surgery or ocular injury within 12 weeks of enrollment for this study. Anterior segment disease, infection, inflammation, or abnormality that contraindicates contact lens wear. History of herpetic keratitis. Slit-lamp findings at baseline as specified in the protocol. Any use of systemic or ocular medications for which contact lens wear could be contraindicated, including ocular medications that require instillation during contact lens wear. Clinically significant dry eye not responding to treatment. History of refractive surgery. Other protocol-defined exclusion criteria may apply.

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iteration 2-87-1<br>Delefilcon A toric contact lenses T1 and T2 worn contralaterally (1 in each eye) for approximately 30 minutes | Device: Delefilcon A toric contact lens T1<br>* Iteration 2-87-1 with embossed mark<br>Device: Delefilcon A toric contact lens T2<br>* Iteration 2-87-1 without embossed mark<br>|
| Experimental: Iteration 2-87-2<br>Delefilcon A toric contact lenses T3 and T4 worn contralaterally (1 in each eye) for approximately 30 minutes | Device: Delefilcon A toric contact lens T3<br>* Iteration 2-87-2 with embossed mark<br>Device: Delefilcon A toric contact lens T4<br>* Iteration 2-87-2 without embossed mark<br>|
| Experimental: Iteration 2-87-3<br>Delefilcon A toric contact lenses T5 and T6 worn contralaterally (1 in each eye) for approximately 30 minutes | Device: Delefilcon A toric contact lens T5<br>* Iteration 2-87-3 with embossed mark<br>Device: Delefilcon A toric contact lens T6<br>* Iteration 2-87-3 without embossed mark<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Lenses With Axis Orientation ≤ 10 Degrees From Ideal Location After 3 Minutes of Wear | Axis orientation (the rotational positioning of the lens on the eye) was indicated by an axis mark. The actual location of the axis mark was evaluated during slit lamp review and compared to the ideal location for the axis mark, with the difference measured in degrees (0 to +/- 180). The ideal location for the axis mark was iteration-specific (either 6 o'clock or 3 and 9 o'clock). This outcome measure was pre-specified for the embossed lenses only (TEST1, TEST3, and TEST5). | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Awareness | Lens awareness was assessed by the participant on a 5-point scale (0=none and 4=severe) within the first 5 minutes of wear for each eye separately. | Day 1 | 
| Handling on Removal | Handling on removal (after 30 minutes of wear) was assessed by the participant on a scale from 1 to 10 (1=poor and 10=excellent). This outcome measure was pre-specified for the embossed lenses only (TEST1, TEST3, and TEST5). | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact Lens, Toric