Clinical Evaluation of Safety and Effectiveness for the Acuity 200 (Fluoroxyfocon A) Rigid Gas Permeable Contact Lens
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Refractive Errors
- Sponsor
- Acuity Polymers, Inc.
- Enrollment
- 74
- Locations
- 3
- Primary Endpoint
- Adverse Events
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Prior to being considered eligible to participate in this study, each subject MUST:
- •Be at least 18 years of age as of the date of evaluation.
- •read the Informed Consent,
- •been given an explanation of the Informed Consent,
- •indicated an understanding of the Informed Consent and
- •signed the Informed Consent Form.
- •Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
- •Be a current contact lens wearer.
- •Possess wearable and visually functional eyeglasses.
- •Be in good general health, based on his/her knowledge.
Exclusion Criteria
- •Subjects may not be enrolled into the study if ANY of the following apply:
- •Subject is wearing lenses in a mono-vision modality and is unwilling to be fit with distance lenses in both eyes. NOTE: Subjects may NOT wear mono-vision lenses at any time during the study as it will interfere with the distance visual acuity measurement.
- •Subject appears to exhibit poor personal hygiene (that in the investigator's opinion might prevent safe contact lens wear).
- •Subject is currently or within 30 days prior to this study has been an active participant in another clinical study.
- •Subject is currently pregnant (to the best of the subject's knowledge), is planning a pregnancy within the next 3 months or is lactating.
- •Subject is a member, relative or household member of the office staff, including the investigator(s).
- •Subject has a known sensitivity to ingredients used in contact lens care products or over-the-counter lubricants and artificial tears.
- •Subject has undergone refractive surgery or is currently receiving or has previously received orthokeratology treatment.
- •Subject is aphakic or pseudophakic.
- •Subject has ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome lupus erythematosus, scleroderma, keratoconus or type II diabetes.
Outcomes
Primary Outcomes
Adverse Events
Time Frame: 90 days
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.
Visual Acuity
Time Frame: 90 days
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.
Slit Lamp Exam Observations
Time Frame: 90 days
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.
Secondary Outcomes
- Subjective Symptoms(90 days)