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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
74
Daily wear rigid gas permeable contact lens
Daily wear rigid gas permeable contact lens
Ala Mona Advanced Eye Clinic
Honolulu, Hawaii, United States
Cornea and Contact Lens Institute of Minnesota
Edina, Minnesota, United States
Reed Eye Associates
Pittsford, New York, United States
Visual Acuity
Comparison of the corrected visual acuity (logMAR) between the Test and Control lens. The working hypothesis is that the visual acuity results will be substantially equivalent between the Test and the Control lenses.
Time frame: 90 days
Slit Lamp Exam Observations
Comparison of slit lamp exam findings (scored from 0-4) between Test and Control arms. The working hypothesis is that the findings will be substantially equivalent between the Test and the Control lenses.
Time frame: 90 days
Adverse Events
Comparison of the number of device related adverse events in the Test and Control arms. The working hypothesis is that the number of adverse events will be substantially equivalent between the Test and the Control lenses.
Time frame: 90 days
Subjective Symptoms
Comparison of subjective symptoms (scored from 0-5) between Test and Control arms. The working hypothesis is that the symptoms will be substantially equivalent between the Test and the Control lenses.
Time frame: 90 days
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