Subjective and Conjunctival Response to Edge Design of Different Silicone Hydrogels

Study Overview
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Brief Summary
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The purpose of this study was to evaluate the effect of different contact lens edge designs on the circumlimbal conjunctiva.

Official Title
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Subjective and Conjunctival Response to Edge Design of Different Silicone Hydrogels

Conditions
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Contact Lenses

Intervention / Treatment
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* Device: Senofilcon A contact lens (Acuvue Oasys)
* Device: Comfilcon A contact lens (Biofinity)
* Device: Lotrafilcon B contact lens (Air Optix)
* Device: Balafilcon A contact lens (PureVision)
* Device: Etafilcon A contact lens (Acuvue 2)
* Device: Contact lens care system (EasySept)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum age of 18 years old Adapted contact lens wearer Sign informed consent Normal eyes with the exception of the need for visual correction Astigmatism less than or equal to -0.75 diopter Spherical prescription range between -10.00 and +6.00 diopters Other protocol-defined inclusion criteria may apply Exclusion Criteria: Any known sensitivity to the test articles used in the study Monocular vision Lid or conjunctival infections or abnormalities Conjunctival staining greater than Grade 1 Corneal staining greater than Grade 2 Corneal edema or opacifications Aphakia Any previous corneal surgery Iritis Recent significant changes in visual acuity Ocular disease that contraindicates contact lens wear Tarsal abnormalities greater than Grade 2 Any ophthalmic medication Any systemic medication or condition that might affect the subject's participation in the study Chronic upper respiratory infections or colds Pregnancy or planning to become pregnant Lactation Seasonal allergies Known infections or immunosuppressive disease Participation in other studies 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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acuvue Oasys<br>One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each. | Device: Senofilcon A contact lens (Acuvue Oasys)<br>* Silicone hydrogel contact lens CE-marked for the intended usage.<br>* Other names: ACUVUE® OASYS™;Device: Contact lens care system (EasySept)<br>* Contact lens care system CE-marked for the intended usage.<br>* Other names: EasySept;|
| Experimental: Biofinity<br>One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each. | Device: Comfilcon A contact lens (Biofinity)<br>* Silicone hydrogel contact lens CE-marked for the intended usage.<br>* Other names: Biofinity®;Device: Contact lens care system (EasySept)<br>* Contact lens care system CE-marked for the intended usage.<br>* Other names: EasySept;|
| Experimental: Air Optix<br>One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each. | Device: Lotrafilcon B contact lens (Air Optix)<br>* Silicone hydrogel contact lens CE-marked for the intended usage.<br>* Other names: Air Optix®;Device: Contact lens care system (EasySept)<br>* Contact lens care system CE-marked for the intended usage.<br>* Other names: EasySept;|
| Experimental: PureVision<br>One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each. | Device: Balafilcon A contact lens (PureVision)<br>* Silicone hydrogel contact lens CE-marked for the intended usage.<br>* Other names: PureVision®;Device: Contact lens care system (EasySept)<br>* Contact lens care system CE-marked for the intended usage.<br>* Other names: EasySept;|
| Active Comparator: Acuvue 2<br>One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each. | Device: Etafilcon A contact lens (Acuvue 2)<br>* Hydrogel contact lens CE-marked for the intended usage.<br>* Other names: ACUVUE® 2;Device: Contact lens care system (EasySept)<br>* Contact lens care system CE-marked for the intended usage.<br>* Other names: EasySept;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circumlimbal Conjunctival Staining (CCS) |  | After 10 days of wear | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contact lenses, conjunctival staining, contact lens wear