NCT01371552

Performance Evaluation of a New Daily Disposable Silicone Hydrogel Lens

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: CIBA VISION · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	delefilcon A contact lens	Investigational, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1 and one week in Part 2.
DEVICE	filcon II 3 contact lenses	Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.
DEVICE	narafilcon A contact lenses	Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2011-06-13
• Last updated: 2012-10-31
• Results posted: 2012-10-31

Locations

1 site across 1 country: Canada