NCT04658797

Clinical Evaluation on Using Personal Face Masks With Spectacles Versus Contact Lenses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: CooperVision, Inc. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The aim of this study was to explore satisfaction with vision correction and ease of use of PFM (Personal Face Masks) in a group of spectacle wearers who were randomised to continue wearing spectacles or be fitted with daily disposable contact lenses.

Detailed description

This was a two arm parallel-group, randomised study. Subjects wearing single vision spectacles were recruited to participate in the study. Subjects were randomised to either continue to use their spectacles or to be fitted with the study daily disposable (DD) contact lens.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	somofilcon A Daily Disposable Contact Lens	Daily Disposable Contact Lens
DEVICE	Single Vision Spectacle for Vision Correction	Single Vision Spectacle
OTHER	Personal Facemask	Personal Facemask

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-04-15
• Completion: 2021-04-30
• First posted: 2020-12-08
• Last updated: 2021-10-20
• Results posted: 2021-10-20

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study