Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Toric Contact Lenses

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the axis orientation of LID226397 toric contact lenses.

Detailed Description
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Subjects will be expected to attend 7 visits including a screening visit. The total duration of a subject's participation in the study will be approximately 40 days.

Official Title
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Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Toric Contact Lenses

Conditions
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Astigmatism, Ametropia, Myopia, Hyperopia

Intervention / Treatment
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* Device: Serafilcon A toric contact lenses
* Device: Senofilcon A toric contact lenses
* Device: CLEAR CARE


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Successful wearers of any commercial soft toric contact lenses (except AOfAHP and daily disposable lenses) in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day. Able to be fit with and wear contact lenses within the available range of sphere & cylinder power and axes. Best corrected distance visual acuity greater than or equal to 20/25 Snellen (0.10 logMAR) in each eye as determined by manifest refraction at screening. Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment. Habitual AOfAHP contact lens wearers and habitual daily disposable lens wearers (worn within last 3 months). Other 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

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: LID226397, then AOfAHP<br>Serafilcon A toric contact lenses worn in Period 1, with senofilcon A toric contact lenses worn in Period 2. Each product will be worn bilaterally (in both eyes) during waking hours for approximately 14 days. CLEAR CARE will be used for nightly contact lens cleaning and disinfection. | Device: Serafilcon A toric contact lenses<br>* Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism)<br>* Other names: LID226397;Device: Senofilcon A toric contact lenses<br>* Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism)<br>* Other names: AOfAHP;Device: CLEAR CARE<br>* Hydrogen peroxide-based contact lens cleaning and disinfecting solution<br>* Other names: CLEAR CARE® Cleaning and Disinfecting Solution;|
| Other: AOfAHP, then LID226397<br>Senofilcon A toric contact lenses worn in Period 1, with serafilcon A toric contact lenses worn in Period 2. Each product will be worn bilaterally (in both eyes) during waking hours for approximately 14 days. CLEAR CARE will be used for nightly contact lens cleaning and disinfection. | Device: Serafilcon A toric contact lenses<br>* Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism)<br>* Other names: LID226397;Device: Senofilcon A toric contact lenses<br>* Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism)<br>* Other names: AOfAHP;Device: CLEAR CARE<br>* Hydrogen peroxide-based contact lens cleaning and disinfecting solution<br>* Other names: CLEAR CARE® Cleaning and Disinfecting Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of lenses with axis orientation within ± 30 degrees from the intended axis at 10 minutes after lens insertion | The investigator will view the contact lens through a slit lamp (biomicroscope) and record the axis orientation (-179° to +180°) as the number of degrees away from the ideal location (90° axis) either positive or negative depending on the direction (nasal [+] or temporal [-]). | Day 1 Dispense, 10 minutes after lens insertion, for each wear period. Each wear period is approximately 14 days. |