NCT04187599

Post-market Follow Up Study on Paragon CRT® 100 (Paflufocon D)

Post-market Follow Up Study on Paragon CRT® 100 (Paflufocon D) Rigid Gas Permeable Contact Lenses for Corneal Refractive Therapy for Temporary Myopic Refractive Power Reduction

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: CooperVision International Limited (CVIL) · Industry
• Sex: All
• Age: 8 Years
• Healthy volunteers: Accepted

Summary

The main objective of this post market clinical study is to evaluate the effectiveness and safety of the Paragon CRT®100 Contact Lens.

Detailed description

This clinical study has two phases: prospective and retrospective. Prospective Phase - evaluates the post-market long-term effectiveness and safety of the Paragon CRT® 100 Contact Lenses, for temporary myopic refractive power reduction with minimum 12-month period follow-up. Retrospective phase - evaluates the post-market long-term safety of the Paragon CRT® 100 Contact Lenses, for temporary myopic refractive power reduction.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	Paragon CRT®100 Contact Lens	Paragon CRT® 100 Contact Lenses for Corneal Refractive Therapy are indicated for use in the reduction of myopic refractive error in nondiseased eyes.

Timeline

• Start date: 2019-08-29
• Primary completion: 2020-11-30
• Completion: 2020-12-31
• First posted: 2019-12-05
• Last updated: 2019-12-05

Locations

4 sites across 1 country: China

Regulatory

• FDA-regulated device study