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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-05-31

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.

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Detailed Description

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Conditions

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Corneal Staining

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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FID 109182

Senofilcon A contact lens pre-soaked in FID 109182 worn in the right or left eye as randomized for 2 hours

Group Type EXPERIMENTAL

FID 109182

Intervention Type DEVICE

Investigational multipurpose contact lens cleaning and disinfecting solution

Senofilcon A contact lens

Intervention Type DEVICE

Commercially available silicone hydrogel contact lens

Opti-Free Plus

Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in the fellow eye for 2 hours

Group Type ACTIVE_COMPARATOR

Opti-Free Plus

Intervention Type DEVICE

Commercially available multipurpose contact lens cleaning and disinfecting solution

Senofilcon A contact lens

Intervention Type DEVICE

Commercially available silicone hydrogel contact lens

Interventions

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FID 109182

Investigational multipurpose contact lens cleaning and disinfecting solution

Intervention Type DEVICE

Opti-Free Plus

Commercially available multipurpose contact lens cleaning and disinfecting solution

Intervention Type DEVICE

Senofilcon A contact lens

Commercially available silicone hydrogel contact lens

Intervention Type DEVICE

Other Intervention Names

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Opti-Free III Opti-Free Plus® Acuvue® Oasys®

Eligibility Criteria

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Inclusion Criteria

* Soft contact lenses habitual wearer, both eyes.
* Voluntarily sign Informed Consent.

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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No