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

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: stenfilcon A lens with solution additive (test); Device: stenfilcon A lens (control)

• Registration Number: NCT03024970
• Lead Sponsor: Coopervision, Inc.

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).

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 Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-19
• Primary Completion: 2017-04-25
• Study Completion: 2017-06-26
• Results First Submitted: 2020-06-19
• Results First Submitted QC: 2020-06-19
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-08
• Results First Posted: 2020-07-09
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Bulbar Hyperemia	1 Month	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)
Visual Acuity On Low Illumination High Contrast	1 Month	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.
Visual Acuity On High Illumination High Contrast	1 Month	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.
Overall Corneal Staining	One Month	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.
Limbal Hyperemia	1 Month	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)
Subjective Ratings on Comfort	1 Month	Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
Vision Satisfaction	1 Month	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
Conjunctival Staining	1 Month	Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent
Palpebral Hyperemia	1 Month	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)

Secondary Outcome Measures

Name	Time	Method
Lens Fit Acceptance	1 Month	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.
Handling Satisfaction	1 Month	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
Subjective Ratings on Dryness	1 Month	Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry
Lens Surface - Wettability	1 Month	Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent
Lens Surface - Deposits	1 Month	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.

Trial Locations

Locations (2)

The Ocular Surface Institute (TOSI); 🇺🇸 Houston, Texas, United States

Clinical Optical Research Lab (CORL); 🇺🇸 Bloomington, Indiana, United States