NCT04067050

A Clinical Study of the Comfilcon A Asphere Soft Contact Lens in Users of Digital Devices

A Clinical Study of the Biofinity Energys Soft Contact Lens in Users of Digital Devices

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: CooperVision, Inc. · Industry
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The aim of this work is to investigate the clinical performance and subjective acceptance of the comfilcon A asphere contact lens when compared to single-vision spectacles in subjects who have never worn contact lenses and who use digital devices (such as phones, tablets, laptops, desktop computers) for at least 4 hours per day on at least 5 days per week.

Detailed description

The aim of this clinical work is to compare the clinical performance and subjective acceptance of comfilcon A asphere contact lens when compared to single-vision spectacles in subjects who use digital devices (phones, tablets, laptops, desktop computers) for at least 4 hours per day on at least 5 days per week. Subjects will be randomized to use either their habitual spectacles or the study contact lenses for two months.

Conditions

• Ametropia

Interventions

Type	Name	Description
DEVICE	comfilcon A asphere	Contact Lens
DEVICE	Spectacles	Habitual spectacles

Timeline

• Start date: 2019-07-04
• Primary completion: 2020-02-28
• Completion: 2020-03-30
• First posted: 2019-08-26
• Last updated: 2021-04-13
• Results posted: 2021-04-13

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study