Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses (QUINCE)

Ciba Vision

Status: Completed

Conditions: Myopia

Treatments: Device: Narafilcon A contact lens; Device: Galyfilcon A contact lens; Device: Lotrafilcon A contact lens

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00934102

P-368-C-103

Details and patient eligibility

About

The purpose of this study is to assess the ophthalmic compatibility of three different silicone hydrogel lenses worn on an overnight basis for six nights.

Enrollment: 57 patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Is at least 17 years of age and has full legal capacity to volunteer
• Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction
• Has had an ocular examination in the last two years
• Is a current soft (hydrogel or silicone hydrogel) contact lens wearer
• Has clear corneas and no active ocular disease
• Can be successfully fit with the lenses to be used in the study
• Other protocol-defined inclusion/exclusion criteria may apply

Exclusion criteria

• Is pregnant or lactating
• Has undergone corneal refractive surgery
• Currently wears lenses on an extended wear basis or was on extended wear within six months prior to the study
• Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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57 participants in 3 patient groups

Lotrafilcon A

Active Comparator group

Description:

Lotrafilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.

Treatment:

Device: Lotrafilcon A contact lens

Narafilcon A

Active Comparator group

Description:

Narafilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.

Treatment:

Device: Narafilcon A contact lens

Galyfilcon A

Active Comparator group

Description:

Galyfilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.

Treatment:

Device: Galyfilcon A contact lens