Refractive ErrorsAcuity 200NCT03971227
Clinical Evaluation of Acuity 200 (Fluoroxyfocon A) RGP Contact Lens
A study testing Acuity 200 (Fluoroxyfocon A) contact lens and Acuity 100 (Hexafocon A) contact lens in people with Refractive Errors, run by Acuity Polymers, Inc. at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors
- What is being tested?
- Acuity 200 (Fluoroxyfocon A) contact lens and Acuity 100 (Hexafocon A) contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Apr 2019to 19 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Have:
- read the Informed Consent,
- been given an explanation of the Informed Consent,
- indicated an understanding of the Informed Consent and
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- 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.
- Require spectacle lens powers between +10.00 and -10.00 diopters sphere with no more than 2.5 diopters of spectacle refractive astigmatism and be willing to wear lenses in both eyes.
- Have manifest refraction visual acuity equal to or better than 0.10 log MAR (20/25 Snellen) in each eye.
Who cannot join
- 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).
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- 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.
- Subject has 2.5 diopters or great of corneal astigmatism.
- Use of ocular medications for any reason or systemic medications which might interfere with contact lens wear.
- A known history of corneal hypoesthesia (reduced corneal sensitivity).
- Slit lamp findings that would contraindicate contact lens wear, including but not limited to:
- History of corneal ulcer, corneal infiltrates or fungal infections
- Corneal scars within the visual axis
- Pterygium
- Dry eye symptoms with decrease tear levels and punctate staining ≥ Grade 2
- Neovascularization or ghost vessels ≥l.5 mm in from the limbus
- Seborrhoeic eczema, seborrhoeic conjunctivitis
- History of papillary conjunctivitis that has interfered with lens wear or a current condition of Grade 2 (Mild) or greater
- Clinically significant (Grade 3 or 4) anterior segment abnormalities or any infection of the eye, lids, or associated structures.
- The investigator for any reason considers that it is not in the best interest of the subject to participate in the study.
- To be eligible to be randomized for study product trial a subject must have ALL of the inclusion criteria and NONE of the exclusion criteria present. To be eligible for lens dispensing, the subject's study device contact lens visual acuity must be equal to or better than 0.20 log MAR (20/32 Snellen) in each eye
- -
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cornea and Contact Lens Institute of Minnesota
Edina, Minnesota, 55436
Ala Mona Advanced Eye Clinic
Honolulu, Hawaii, 96814
Reed Eye Associates
Pittsford, New York, 14534
About this study
Official title: Clinical Evaluation of Safety and Effectiveness for the Acuity 200 (Fluoroxyfocon A) Rigid Gas Permeable Contact Lens
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.
Read the 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
- Being tested
- Acuity 200 (Fluoroxyfocon A) contact lens, Acuity 100 (Hexafocon A) contact lens
- Keywords
- refractive, permeable, lens, rigid, gas, myopia
- Medical subject headings
- Refractive Errors, Muscle Rigidity, Mucopolysaccharidosis IV, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acuity 200 (Fluoroxyfocon A) contact lensDevice
Daily wear rigid gas permeable contact lens
Acuity 100 (Hexafocon A) contact lensDevice
Daily wear rigid gas permeable contact lens
| Study group | Role | What they receive |
|---|---|---|
| Acuity 200 contact lens | Experimental | Rigid gas permeable contact lens for daily wear, fluoroxyfocon A Receives: Device: Acuity 200 (Fluoroxyfocon A) contact lens |
| Acuity 100 contact lens | Active comparator | Rigid gas permeable contact lens for daily wear, hexafocon A Receives: Device: Acuity 100 (Hexafocon A) contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 90 days
Secondary outcomes (1)
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start1 Apr 2019
- Primary completion19 Mar 2020
- Study completion19 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This is an open-label, multi-center, randomized concurrent-control study with the treatment duration of 90 days.
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acuity Polymers, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Andre Vision and Device Research
- Responsible party
- Sponsor
- Investigators
- James A Bonafini, BS,MS, Study chair, Acuity Polymers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971227
- Sponsor's protocol ID
- AVDR 2019-02 v1.0
- Acronym
- Acuity 200
- Status last verified
- Jan 2020
- First submitted
- 30 May 2019
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Safety and Effectiveness for the Acuity 200 (Fluoroxyfocon A) Rigid Gas Permeable Contact Lens
- ClinicalTrials.gov ID
- NCT03971227
- Acronym / sponsor ID
- Acuity 200 / AVDR 2019-02 v1.0
- Conditions
- Refractive Errors
- Keywords
- refractive, permeable, lens, rigid, gas, myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Acuity Polymers, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Andre Vision and Device Research
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an open-label, multi-center, randomized concurrent-control study with the treatment duration of 90 days.
| Arm | Type | Receives |
|---|---|---|
| Acuity 200 contact lens | Experimental | Device: Acuity 200 (Fluoroxyfocon A) contact lensRigid gas permeable contact lens for daily wear, fluoroxyfocon A |
| Acuity 100 contact lens | Active comparator | Device: Acuity 100 (Hexafocon A) contact lensRigid gas permeable contact lens for daily wear, hexafocon A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Be at least 18 years of age as of the date of evaluation.
- Have:
- 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.
Key exclusion criteria (25 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acuity 200 (Fluoroxyfocon A) contact lensDaily wear rigid gas permeable contact lens | Device | Acuity 200 contact lens |
| Acuity 100 (Hexafocon A) contact lensDaily wear rigid gas permeable contact lens | Device | Acuity 100 contact lens |
Primary outcome
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.
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.
1 secondary outcome
Subjective Symptoms
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James A Bonafini, BS,MS study chair
Acuity Polymers
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acuity 200 (Fluoroxyfocon A) contact lens and Acuity 100 (Hexafocon A) contact lens in people with Refractive Errors, run by Acuity Polymers, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity (time frame: 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.