NCT04050618

Brief Summary

To evaluate the comparative clinical performance of the fanfilcon A silicone hydrogel lens used in daily wear and to compare this with competitive hydrogel lens products.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

6 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

June 9, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2019

Completed
12 months until next milestone

Results Posted

Study results publicly available

October 19, 2020

Completed
Last Updated

October 19, 2020

Status Verified

September 1, 2020

Enrollment Period

4 months

First QC Date

August 7, 2019

Results QC Date

September 24, 2020

Last Update Submit

September 24, 2020

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

  • Subjective Overall Comfort Rating

    Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses

    Two weeks

  • Subjective Overall Comfort Rating

    Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses

    Four weeks

Secondary Outcomes (45)

  • Average Wearing Time

    Two weeks

  • Average Wearing Time

    Four weeks

  • Average Comfortable Wearing Time

    Two weeks

  • Average Comfortable Wearing Time

    Four weeks

  • Lens Centration

    Baseline (after 15 minutes)

  • +40 more secondary outcomes

Study Arms (2)

ocufilcon D control lens, then fanfilcon A test lens

EXPERIMENTAL

Participants will wear the ocufilcon D control lens for 4 weeks, then crossover to fanfilcon A test lens for 4 weeks of daily wear.

Device: fanfilcon A test lensDevice: ocufilcon D control lens

etafilcon A controls, then fanfilcon A test lens

EXPERIMENTAL

Participants will wear the etafilcon D control lens for 2 weeks, then crossover to fanfilcon A test lens for 2 weeks of daily wear.

Device: fanfilcon A test lensDevice: etafilcon A control lens

Interventions

fanfilcon A test lensDEVICE

Silicone hydrogel contact lens

Also known as: test lens, Avaira Vitality
etafilcon A controls, then fanfilcon A test lensocufilcon D control lens, then fanfilcon A test lens
ocufilcon D control lensDEVICE

hydrogel contact lens

Also known as: Biomedics 55 Premier, ocufilcon D (4-weekly) control lens
ocufilcon D control lens, then fanfilcon A test lens
etafilcon A control lensDEVICE

hydrogel contact lens

Also known as: etafilcon A (2-weekly) control lens, Acuvue 2
etafilcon A controls, then fanfilcon A test lens

Eligibility Criteria

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

You may qualify if:

  • Be a currently adapted soft contact lens wearer (\>1 month of lens wear).
  • Be at least 18 years of age.
  • Refractive astigmatism \<1.00D in both eyes.
  • Have clear corneas and be free of any anterior segment disorders.
  • Be correctable through spherocylindrical refraction to 20/25 or better in each eye.
  • Contact lens sphere requirement between -1.00D and -6.00D (inclusive).
  • Require visual correction in both eyes (monovision allowed, no monofit).
  • Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
  • No amblyopia
  • No strabismus
  • No evidence of lid abnormality or infection
  • No conjunctival abnormality or infection that would contraindicate contact lens wear
  • No clinically significant slit lamp findings (i.e. corneal staining, stromal edema, staining, scarring, vascularization, infiltrates or abnormal opacities)
  • No other active ocular disease.
  • Own a mobile phone and be able to respond to SMS survey during the period 8am-8pm.
  • +1 more criteria

You may not qualify if:

  • Using CooperVision Avaira Vitality, J\&J Acuvue 2 or CooperVision Biomedics 55.
  • Require toric or multifocal contact lenses.
  • Previously shown a sensitivity to any of the study solution components.
  • Any systemic or ocular disease or allergies affecting ocular health.
  • Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or lens performance.
  • Clinically significant (\>Grade 3) corneal staining, corneal stromal edema, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
  • Any corneal infiltrates or any corneal scarring or neovascularization within the central 5mm of the cornea.
  • Keratoconus or other corneal irregularity.
  • Aphakia or amblyopia.
  • Have undergone corneal refractive surgery or any anterior segment surgery.
  • Abnormal lacrimal secretions.
  • Has diabetes.
  • Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
  • History of chronic eye disease (e.g. glaucoma).
  • Pregnant or lactating or planning a pregnancy at the time of enrolment.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Golden Optometric Group

Whittier, California, 90606, United States

Location

Omega Vision Center PA (DBA Sabal Eye Care)

Longwood, Florida, 32779, United States

Location

Golden Vision

Sarasota, Florida, 34232, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

Frazier Vision, Inc

Tyler, Texas, 75703, United States

Location

Office of William J. Bogus, O.D.

Salt Lake City, Utah, 84106, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Jose A. Vega, O.D., MSc, FAAO
Organization
CooperVision, Inc.
javega@coopervision.com
925-621-3761

Study Officials

  • David C Ardaya, OD

    Golden Optometric Group

    PRINCIPAL INVESTIGATOR

  • William J Bogus, OD

    Office of William J. Bogus, O.D.

    PRINCIPAL INVESTIGATOR

  • Bryan E Frazier, OD

    Frazier Vision, Inc

    PRINCIPAL INVESTIGATOR

  • Wayne Golden, OD

    Golden Vision

    PRINCIPAL INVESTIGATOR

  • Andrew J Sacco, OD

    Sacco Eye Group

    PRINCIPAL INVESTIGATOR

  • Christopher Pearson, OD

    Omega Vision Center PA (DBA Sabal Eye Care)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Subjects will be masked to lens type. Investigators will be unmasked.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2019

First Posted

August 8, 2019

Study Start

June 9, 2019

Primary Completion

September 24, 2019

Study Completion

November 8, 2019

Last Updated

October 19, 2020

Results First Posted

October 19, 2020

Record last verified: 2020-09

Locations

US(6)