Evaluation of Deposits on Contact Lenses Worn Extended Wear

Alcon

Status: Completed

Conditions: Myopia

Treatments: Device: etafilcon A contact lens (Acuvue2); Device: balafilcon A contact lens (PureVision)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00725530

MS-007

Details and patient eligibility

About

The purpose of this study was to measure lipid deposits on commercially marketed contact lenses when worn on an extended wear (overnight) basis for 7 days.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 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.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Evidence or history of ocular conditions as prescribed in the protocol.
• One functional eye or a monofit lens.
• Any slit-lamp finding score of (1) at the Screening Visit as defined by the protocol.
• Use of concomitant topical ocular prescription or over-the-counter ocular medications.
• History of seasonal allergies with significant ocular side effects.
• Other protocol-defined exclusion criteria may apply.

Trial design

54 participants in 2 patient groups

balafilcon A / etafilcon A

Active Comparator group

Description:

Balafilcon A worn first, with etafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days.

Treatment:

Device: balafilcon A contact lens (PureVision)

Device: etafilcon A contact lens (Acuvue2)

etafilcon A / balafilcon A

Active Comparator group

Description:

Etafilcon A worn first, with balafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days.

Treatment:

Device: balafilcon A contact lens (PureVision)

Device: etafilcon A contact lens (Acuvue2)