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

Refractive Errors Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Refractive Errors

• NCT number: NCT03971227
• Study type: Interventional
• Source: Acuity Polymers, Inc.
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Completion date: March 19, 2020