Clinical Performance Evaluation of Two Daily Disposable Silicone Hydrogel Toric Contact Lenses

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the rotational behavior of DT1 Toric contact lenses.

Detailed Description
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This is a single visit, non-dispense study where subjects will be exposed to the test and control lenses for approximately 1 hour each.

Official Title
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Clinical Performance Evaluation of Two Daily Disposable Silicone Hydrogel Toric Contact Lenses

Conditions
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Refractive Errors

Intervention / Treatment
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* Device: DT1 Toric contact lenses
* Device: AO1DfA contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current wearer of any commercial soft daily wear contact lens with at least 3 months of wearing experience with a minimum wearing time of 5 days per week and 8 hours per day. Requiring contact lens (manifest refraction) of a cylindrical power of -0.75 to -2.50 diopter cylinder (DC). Best corrected distance visual acuity 20/25 or better Snellen in each eye (as determined by manifest refraction at screening). Willing to NOT use rewetting/lubricating drops at any time during the study. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator. Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator. History of refractive surgery or plan to have refractive surgery during the study or irregular cornea in either eye. Eye injury in either eye within 12 weeks immediately prior to enrollment for this trial. 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

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Test, then Control<br>DT1 Toric contact lenses worn first, followed by AO1DfA contact lenses, as randomized. Each product will be worn in both eyes for approximately 1 hour. | Device: DT1 Toric contact lenses<br>* Delefilcon A contact lenses for the optical correction of astigmatism in people with healthy eyes with or without refractive ametropia (myopia or hyperopia)<br>* Other names: DAILIES TOTAL1 for Astigmatism (DT1 Toric);Device: AO1DfA contact lenses<br>* Senofilcon A contact lenses for the optical correction of astigmatism in people with healthy eyes with or without refractive ametropia (myopia or hyperopia)<br>* Other names: Acuvue Oasys 1-Day for Astigmatism (AO1DfA);|
| Other: Control, then Test<br>AO1DfA contact lenses worn first, followed by DT1 Toric contact lenses, as randomized. Each product will be worn in both eyes for approximately 1 hour. | Device: DT1 Toric contact lenses<br>* Delefilcon A contact lenses for the optical correction of astigmatism in people with healthy eyes with or without refractive ametropia (myopia or hyperopia)<br>* Other names: DAILIES TOTAL1 for Astigmatism (DT1 Toric);Device: AO1DfA contact lenses<br>* Senofilcon A contact lenses for the optical correction of astigmatism in people with healthy eyes with or without refractive ametropia (myopia or hyperopia)<br>* Other names: Acuvue Oasys 1-Day for Astigmatism (AO1DfA);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of DT1 toric lenses with axis orientation within ±30° from the intended axis, 10 min after lens insertion | A slit lamp will be used to observe axis orientation. | Day 1, 10 minutes after lens insertion, each product | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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toric contact lens, daily disposable, silicone hydrogel contact lens, axis orientation, astigmatism