Performance Evaluation of a New Daily Disposable Silicone Hydrogel Lens

Performance Evaluation of a New Daily Disposable Silicone Hydrogel Lens (TUNGSTEN)

The purpose of this study was to compare a new daily disposable, silicone hydrogel contact lens to marketed daily disposable, silicone hydrogel contact lenses.

Part 1 of the study involved bilateral wear of three different types of marketed contact lenses. Each type of lens was worn for three consecutive days of daily disposable wear. Participants had been previously identified as symptomatic lens wearers or asymptomatic lens wearers, based upon their responses to a screening questionnaire. Participants wore each lens type for as long as they were comfortable during the day, but lenses were removed before sleep. After completion of Part 1, participants began Part 2, which included dispensing of the investigational study lens for up to one week of bilateral wear, with a single follow-up visit at the end of that period.

Inclusion Criteria:

• 17 years of age; full legal capacity to volunteer.
• Ocular examination within the last two years
• Correctable to a visual acuity of 20/30 or better (in each eye) with habitual vision correction.
• Currently wearing soft contact lenses.
• Clear corneas; no active ocular disease.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Currently wearing 1-DAY ACUVUE TruEye or Sauflon Clariti 1-DAY contact lenses.
• Monovision.
• Any ocular disease.
• Never worn contact lenses before.
• Corneal refractive surgery.
• Uses topical ocular medicine.
• Other protocol-defined exclusion criteria may apply.