Clinical Evaluation of Opti-Free III (FID 109182) Compared to Opti-Free Plus® in Japan

Study Overview
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Brief Summary
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The purpose of this study is to compare an investigational contact lens care product (FID 109182) to a commercially available contact lens product (Opti-Free Plus®) for corneal staining when used with Acuvue® Oasys® contact lenses. The contact lenses will be pre-soaked in the products for 24-48 hours prior to a 2-hour contralateral wear period.

Official Title
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Clinical Evaluation of Opti-Free III Compared to Opti-Free Plus®

Conditions
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Corneal Staining

Intervention / Treatment
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* Device: FID 109182
* Device: Opti-Free Plus
* Device: Senofilcon A contact lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Soft contact lenses habitual wearer, both eyes. Voluntarily sign Informed Consent. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Unable to tolerate the ingredients in Opti-Free® and similar contact lens care products. Potential use of eye drops during the study, including over-the-counter products, except for artificial tear eye drops. Eye infection, blepharitis, iris inflammation, or severe eye inflammation. Corneal staining greater than Grade 1 at baseline. Pregnant, lactating, or intend to become pregnant during study period. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 20 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FID 109182<br>Senofilcon A contact lens pre-soaked in FID 109182 worn in the right or left eye as randomized for 2 hours | Device: FID 109182<br>* Investigational multipurpose contact lens cleaning and disinfecting solution<br>* Other names: Opti-Free III;Device: Senofilcon A contact lens<br>* Commercially available silicone hydrogel contact lens<br>* Other names: Acuvue® Oasys®;|
| Active Comparator: Opti-Free Plus<br>Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in the fellow eye for 2 hours | Device: Opti-Free Plus<br>* Commercially available multipurpose contact lens cleaning and disinfecting solution<br>* Other names: Opti-Free Plus®;Device: Senofilcon A contact lens<br>* Commercially available silicone hydrogel contact lens<br>* Other names: Acuvue® Oasys®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein | The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining density was evaluated for each eye individually against representative pictures and scored on a 0-3 scale (0=No staining; 1=Staining with low density; 2=Staining with moderate density; 3=Staining with severe density). Proportion of participants is reported as a percentage. | Day 1, after 2 hours of wear | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants Scoring ≥ 2 for Corneal Staining Area With Fluorescein | The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining area was evaluated for each eye individually against representative pictures and scored on a 0-3 scale [0=No staining; 1=Staining with small area (1 to 25% of corneal surface); 2=Staining with medium area (26 to 50% of corneal surface); 3=Staining with large area (51% of corneal surface or greater)]. Proportion of participants is reported as a percentage. | Day 1, after 2 hours of wear | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contact lenses, contact lens solution, corneal staining, fluorescein