Visual Performance Investigation of Two Toric Soft Contact Lenses

Study Overview
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Brief Summary
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The purpose of this study is to compare the amount of coma as measured by aberrometry induced by two silicone hydrogel toric lenses in astigmatic participants.

Official Title
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Visual Performance Investigation of Two Toric Soft Contact Lenses

Conditions
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Astigmatism, Refractive Error, Myopia, Hyperopia

Intervention / Treatment
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* Device: Lotrafilcon B toric contact lens
* Device: Comfilcon A toric contact lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign informed consent; Wears toric soft contact lenses; Can be successfully fit with study lenses within the power ranges available; Has cylinder of ≥ -0.75 diopter in both eyes; Has correctable vision of at least 0.1 (logMAR) or better in each eye at distance with both study lenses; Willing and able to wear study lenses on a daily wear basis for at least 5 days a week, minimum 8 hours per day, and attend all study visits; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Any ocular condition that would contraindicate contact lens wear; Use of medications for which contact lens wear could be contraindicated; Monocular (only 1 eye with functional vision) or fit with 1 lens; History of herpetic keratitis, ocular surgery, or irregular cornea; Known sensitivity to the diagnostic pharmaceuticals to be used in the study; Requires presbyopic correction; Use of rewetting/lubricating eye-drops more than twice a day; 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: AO for Astig / Biofinity Toric<br>Lotrafilcon B toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses in Period 2, as randomized. Each product will be worn bilaterally on a daily wear basis for 30 days, removed nightly. A minimum 1-day washout of no contact lens wear will precede each wear period. | Device: Lotrafilcon B toric contact lens<br>* Commercially available, silicone hydrogel contact lens for correction of astigmatism<br>* Other names: AIR OPTIX® for ASTIGMATISM;Device: Comfilcon A toric contact lens<br>* Commercially available, silicone hydrogel contact lens for correction of astigmatism<br>* Other names: Biofinity® Toric;|
| Other: Biofinity Toric / AO for Astig<br>Comfilcon A toric contact lenses worn in Period 1, followed by lotrafilcon B toric contact lenses in Period 2, as randomized. Each product will be worn bilaterally on a daily wear basis for 30 days, removed nightly. A minimum 1-day washout of no contact lens wear will precede each wear period. | Device: Lotrafilcon B toric contact lens<br>* Commercially available, silicone hydrogel contact lens for correction of astigmatism<br>* Other names: AIR OPTIX® for ASTIGMATISM;Device: Comfilcon A toric contact lens<br>* Commercially available, silicone hydrogel contact lens for correction of astigmatism<br>* Other names: Biofinity® Toric;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Ocular Coma Score at 5mm Pupil at Day 30 | Ocular coma is a type of optical aberration or a distortion in image formation occurring when a bundle of light rays enters an optical system (eye) that is not parallel to the optic axis. Ocular coma will be measured in micrometers using a Ladarwave aberrometer. A lower number indicates less coma/less image distortion. One eye (right eye) contributed to the mean. | Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myopia, hyperopia, astigmatism, contact lenses