NCT03971227

Clinical Evaluation of Acuity 200 (Fluoroxyfocon A) RGP Contact Lens

Clinical Evaluation of Safety and Effectiveness for the Acuity 200 (Fluoroxyfocon A) Rigid Gas Permeable Contact Lens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Acuity Polymers, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this clinical investigation is to collect valid scientific safety and effectiveness data on the Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens, manufactured from a newly developed rigid gas permeable material that is highly permeable to oxygen. The clinical performance data reported from this study is intended to be submitted to the U.S. Food and Drug Administration Center for Devices and Radiological Health (CDRH) in support of a 510(k) premarket notification.

Detailed description

This is an open-label, multi-center, randomized concurrent-control study with the treatment duration of 90 days. Subjects will be recruited into the study based upon the inclusion and exclusion criteria provided. Eligible subjects will be examined for baseline evaluation and lens fitting. Up to sixty (60) subjects will wear the test contact lenses for daily wear and up to twenty-eight (28) subjects will wear the control contact lenses. The subjects will attend seven scheduled study visits and will undergo standard ophthalmic evaluation for contact lens care. The subjects will be followed for a period of three months (90 days) following dispensing of the Test and Control Device.

Conditions

• Refractive Errors

Interventions

Type	Name	Description
DEVICE	Acuity 200 (Fluoroxyfocon A) contact lens	Daily wear rigid gas permeable contact lens
DEVICE	Acuity 100 (Hexafocon A) contact lens	Daily wear rigid gas permeable contact lens

Timeline

• Start date: 2019-04-01
• Primary completion: 2020-03-19
• Completion: 2020-03-19
• First posted: 2019-06-03
• Last updated: 2020-05-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study