NCT03024970

Brief Summary

The purpose of this study is to investigate the overall clinical performance of the test daily disposable stenfilcon A lens with solution additive (test) compared to the stenfilcon A lens (control).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 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

January 1, 2017

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2017

Completed
3 years until next milestone

Results Posted

Study results publicly available

July 9, 2020

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

January 17, 2017

Results QC Date

June 19, 2020

Last Update Submit

July 8, 2020

Conditions

Myopia

Outcome Measures

Primary Outcomes (22)

  • Subjective Ratings on Comfort

    Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable

    Baseline

  • Subjective Ratings on Comfort

    Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable

    1 Week

  • Subjective Ratings on Comfort

    Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable

    1 Month

  • Vision Satisfaction

    Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree

    Baseline

  • Vision Satisfaction

    Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree

    1 week

  • Vision Satisfaction

    Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree

    1 Month

  • Visual Acuity On High Illumination High Contrast

    Visual acuity is assessed on high illumination high contrast logMAR charts for test and control lenses. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.

    Baseline

  • Visual Acuity On High Illumination High Contrast

    Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.

    1 Week

  • Visual Acuity On High Illumination High Contrast

    Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.

    1 Month

  • Visual Acuity On Low Illumination High Contrast

    Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.

    Baseline

  • Visual Acuity On Low Illumination High Contrast

    Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.

    1 Week

  • Visual Acuity On Low Illumination High Contrast

    Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.

    1 Month

  • Overall Corneal Staining

    Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.

    One Week

  • Overall Corneal Staining

    Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.

    One Month

  • Conjunctival Staining

    Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent

    1 Week

  • Conjunctival Staining

    Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent

    1 Month

  • Bulbar Hyperemia

    Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)

    1 Week

  • Bulbar Hyperemia

    Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)

    1 Month

  • Limbal Hyperemia

    Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)

    1 Week

  • Limbal Hyperemia

    Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)

    1 Month

  • Palpebral Hyperemia

    Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)

    1 Week

  • Palpebral Hyperemia

    Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)

    1 Month

Secondary Outcomes (14)

  • Lens Fit Acceptance

    Baseline

  • Lens Fit Acceptance

    1 week

  • Lens Fit Acceptance

    1 Month

  • Handling Satisfaction

    1 week

  • Handling Satisfaction

    1 Month

  • +9 more secondary outcomes

Study Arms (2)

stenfilcon A lens with solution additive (test)

EXPERIMENTAL

Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.

Device: stenfilcon A lens with solution additive (test)Device: stenfilcon A lens (control)

stenfilcon A lens (control)

ACTIVE COMPARATOR

Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.

Device: stenfilcon A lens with solution additive (test)Device: stenfilcon A lens (control)

Interventions

stenfilcon A lens with solution additive (test)DEVICE

silicone hydrogel lens

stenfilcon A lens (control)stenfilcon A lens with solution additive (test)
stenfilcon A lens (control)DEVICE

contact lens

stenfilcon A lens (control)stenfilcon A lens with solution additive (test)

Eligibility Criteria

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

You may qualify if:

  • Has had a self-reported oculo-visual examination in the last two years.
  • Is at least 18 years of age and has full legal capacity to volunteer.
  • Has read and understood the information consent letter.
  • Is willing and able to follow instructions and maintain the appointment schedule.
  • Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
  • Must achieve 20/30 or better (in each eye) with study lenses
  • Requires spectacle lens powers between -0.75 and -6.50 diopters sphere (0.25D steps).
  • Has no more than 0.75 diopters of refractive astigmatism.
  • Currently wears soft contact lenses.
  • Have clear corneas and no active ocular disease.
  • Has not worn lenses for at least 12 hours before the examination

You may not qualify if:

  • A person will be excluded from the study if he/she:
  • Has never worn contact lenses before.
  • Has any systemic disease affecting ocular health.
  • Is using any systemic or topical medications that will affect ocular health.
  • Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
  • Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
  • Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
  • Is aphakic.
  • Has undergone corneal refractive surgery.
  • Is pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
  • Have taken part in any other contact lens or care solution clinical trial or research, within one week prior to starting this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinical Optical Research Lab (CORL)

Bloomington, Indiana, 47405, United States

Location

The Ocular Surface Institute (TOSI)

Houston, Texas, 77204, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Myhanh Nguyen, OD, FAAO
Organization
CooperVision, Inc.
mnguyen@coopervision.com
925-730-6716

Study Officials

  • Pete Kollbaum, OD, PhD

    Clinical Optics Research Lab (CORL) Indiana University School of Optometry.

    PRINCIPAL INVESTIGATOR

  • Eric Ritchey, OD, PhD, FAAO

    University of Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2017

First Posted

January 19, 2017

Study Start

January 1, 2017

Primary Completion

April 25, 2017

Study Completion

June 26, 2017

Last Updated

July 21, 2020

Results First Posted

July 9, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)