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

NCT03971227 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2020-05-12

No results posted yet for this study

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.

Conditions

  • Refractive Errors

Interventions

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

Sponsors & Collaborators

  • Andre Vision and Device Research

    collaborator UNKNOWN

  • Acuity Polymers, Inc.

    lead INDUSTRY

Principal Investigators

  • James A Bonafini, BS,MS · Acuity Polymers

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2020-03-19
Completion
2020-03-19
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03971227 on ClinicalTrials.gov