NCT03006458

A Clinical Comparison of 2 Multifocal Toric XR (Extended Range) Contact Lenses

A Clinical Comparison of the Comfilcon A (Extended Range) XR Toric Multifocal and Omafilcon B Toric XR Multifocal Contact Lenses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: CooperVision, Inc. · Industry
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study aims to compare the clinical performance and subjective acceptance of the comfilcon A and the omafilcon B soft contact lenses.

Detailed description

This will be a randomized, subject-masked, crossover, bilateral study, controlled by cross comparison. Thirty subjects will use each lens type for two weeks in random sequence. Follow-up visits for each lens will be performed after two weeks of wear. Lenses will be worn on a daily wear basis. The final optical design of comfilcon A contact lens was optimized to improve the quality and two further studies (CV-18-10 and CV-18-11) were conducted after completion of this study to evaluate the modified optical design.

Conditions

• Astigmatism

Interventions

Type	Name	Description
DEVICE	comfilcon A	toric contact lens
DEVICE	omafilcon B	toric contact lens

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-04-06
• Completion: 2017-04-06
• First posted: 2016-12-30
• Last updated: 2020-06-01
• Results posted: 2020-06-01

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study