Daily Disposable Dispensing Clinical Trial of Test Lens Against Stenfilcon A Lens

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).

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: stenfilcon A lens with solution additive (test); Device: stenfilcon A lens (control)

Detailed Description

This will be, prospective, multicenter, double-masked, randomized, bilateral, 1 month cross-over, dispensing study comparing the test lens against the stenfilcon A control lens with a study duration of approximately two months.

Each subject will be randomized to wear either the test or control as a matched pair first and subjects will be randomized based on the order in which the subject is enrolled and qualified into the study.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • Clinical Optical Research Lab (CORL)
  • Texas
    • Houston, Texas, United States, 77204
      • The Ocular Surface Institute (TOSI)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A person is eligible for inclusion in the study if he/she:

  • 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: stenfilcon A lens with solution additive (test); 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); silicone hydrogel lens; Device: stenfilcon A lens (control); contact lens
ACTIVE_COMPARATOR: stenfilcon A lens (control); 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); silicone hydrogel lens; Device: stenfilcon A lens (control); contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Fit Acceptance	Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.	Baseline
Lens Fit Acceptance	Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.	1 week
Lens Fit Acceptance	Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.	1 Month
Handling Satisfaction	Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree	1 week
Handling Satisfaction	Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree	1 Month
Lens Surface - Wettability	Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent	Baseline
Lens Surface - Wettability	Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent	1 Week
Lens Surface - Wettability	Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent	1 Month
Lens Surface - Deposits	Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.	Baseline
Lens Surface - Deposits	Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.	1 week
Lens Surface - Deposits	Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.	1 Month
Subjective Ratings on Dryness	Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry	Baseline
Subjective Ratings on Dryness	Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry	1 week
Subjective Ratings on Dryness	Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry	1 Month

Collaborators and Investigators

• Sponsor: Coopervision, Inc.
• Investigators: Principal Investigator: Pete Kollbaum, OD, PhD, Clinical Optics Research Lab (CORL) Indiana University School of Optometry.; Principal Investigator: Eric Ritchey, OD, PhD, FAAO, University of Houston

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (ACTUAL): April 25, 2017
• Study Completion (ACTUAL): June 26, 2017

Study Registration Dates

• First Submitted: January 17, 2017
• First Submitted That Met QC Criteria: January 17, 2017
• First Posted (ESTIMATE): January 19, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CV-16-60

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes