Evaluation of Daily Disposable Lenses With Multi-Purpose Solution (MPS)

Alcon

Status: Completed

Conditions: Myopia

Treatments: Device: Etafilcon A contact lens; Device: Nelfilcon A contact lens; Device: FID 107027 solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00733291

MS-008

Details and patient eligibility

About

The purpose of this study is to evaluate daily disposable lenses inserted out of the blister package versus daily disposable lenses inserted after a pre-soak in Multi-purpose solution FID 107027.

Full description

Corneal staining and subjective responses for ocular redness and comfort will be compared.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older.
• Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses.
• Successfully wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis for at least two weeks prior to study.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• History of hypersensitivity to any components of the multi-purpose solution.
• Evidence or history of ocular conditions as prescribed in protocol.
• One functional eye or a monofit lens
• Any slit-lamp finding score equal to 1 at Visit 1 of each study period.
• Significant corneal staining at visit 1 of each study period as prescribed in protocol.
• Other protocol-defined exclusion criteria may apply.

Trial design

64 participants in 4 patient groups

Nelfilcon A soak / Nelfilcon A no-soak

Active Comparator group

Description:

Nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by nelfilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours.

Treatment:

Device: FID 107027 solution

Device: Nelfilcon A contact lens

Nelfilcon A no soak / nelfilcon A soak

Active Comparator group

Description:

Nelfilcon A contact lenses inserted directly from the blister package, followed by nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours.

Treatment:

Device: FID 107027 solution

Device: Nelfilcon A contact lens

Etafilcon A soak / etafilcon A no soak

Active Comparator group

Description:

Etafilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by etafilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours.

Treatment:

Device: FID 107027 solution

Device: Etafilcon A contact lens

Etafilcon A no soak / etafilcon A soak

Active Comparator group

Description:

Etafilcon A contact lenses inserted directly from the blister package, followed by etafilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours.

Treatment:

Device: FID 107027 solution

Device: Etafilcon A contact lens