NCT02801006

The Clinical Study of Silicone Hydrogel Daily Disposable Stenfilcon A Toric Lens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: CooperVision, Inc. · Industry
• Sex: All
• Age: 18 Years – 42 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to evaluate the clinical performance of stenfilcon A toric lenses compared with etafilcon A toric lenses for astigmatism. If it is valuable, the clinical performance of stenfilcon A toric lens is also evaluated compared with habitual lenses.

Detailed description

This is a multi-sites, 50 subjects, randomized, open labeled, bilateral wear, dispensing study. Participants will be randomized to wear first lens pair for two weeks, and then crossover to second lens pair for two weeks.

Conditions

• Astigmatism

Interventions

Type	Name	Description
DEVICE	stenfilcon A	contact lens
DEVICE	etafilcon A	contact lens

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-06-01
• Completion: 2016-10-31
• First posted: 2016-06-15
• Last updated: 2018-01-09
• Results posted: 2017-12-12

Locations

2 sites across 1 country: Japan

Regulatory

• FDA-regulated device study