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

Alcon

Status: Completed

Conditions: Corneal Staining

Treatments: Device: Senofilcon A contact lens; Device: Opti-Free Plus; Device: FID 109182

Study type: Interventional

Funder types: Industry

Identifiers

NCT02251561

CVKK2013-01

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

36 participants in 2 patient groups

FID 109182

Experimental group

Description:

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

Treatment:

Device: FID 109182

Device: Senofilcon A contact lens

Opti-Free Plus

Active Comparator group

Description:

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

Treatment:

Device: Senofilcon A contact lens

Device: Opti-Free Plus