NCT03971227

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2020

Completed
Last Updated

May 12, 2020

Status Verified

January 1, 2020

Enrollment Period

12 months

First QC Date

May 30, 2019

Last Update Submit

May 11, 2020

Conditions

Refractive Errors

Keywords

refractivepermeablelensrigidgasmyopia

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    90 days

Secondary Outcomes (1)

  • Subjective Symptoms

    90 days

Study Arms (2)

Acuity 200 contact lens

EXPERIMENTAL

Rigid gas permeable contact lens for daily wear, fluoroxyfocon A

Device: Acuity 200 (Fluoroxyfocon A) contact lens

Acuity 100 contact lens

ACTIVE COMPARATOR

Rigid gas permeable contact lens for daily wear, hexafocon A

Device: Acuity 100 (Hexafocon A) contact lens

Interventions

Acuity 200 (Fluoroxyfocon A) contact lensDEVICE

Daily wear rigid gas permeable contact lens

Acuity 200 contact lens
Acuity 100 (Hexafocon A) contact lensDEVICE

Daily wear rigid gas permeable contact lens

Acuity 100 contact lens

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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.
  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ala Mona Advanced Eye Clinic

Honolulu, Hawaii, 96814, United States

Location

Cornea and Contact Lens Institute of Minnesota

Edina, Minnesota, 55436, United States

Location

Reed Eye Associates

Pittsford, New York, 14534, United States

Location

MeSH Terms

Conditions

Refractive ErrorsMuscle RigidityMucopolysaccharidosis IVMyopia

Interventions

Contact Lenses

Condition Hierarchy (Ancestors)

Eye DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMucopolysaccharidosesCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLysosomal Storage DiseasesMucinosesConnective Tissue DiseasesSkin and Connective Tissue DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and Supplies

Study Officials

  • James A Bonafini, BS,MS

    Acuity Polymers

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is an open-label, multi-center, randomized concurrent-control study with the treatment duration of 90 days.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2019

First Posted

June 3, 2019

Study Start

April 1, 2019

Primary Completion

March 19, 2020

Study Completion

March 19, 2020

Last Updated

May 12, 2020

Record last verified: 2020-01

Locations

US(3)