Daily Disposable Dispensing Clinical Trial of Test Lens Against Stenfilcon A Lens
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- CooperVision, Inc.
- Enrollment
- 72
- Locations
- 2
- Primary Endpoint
- Bulbar Hyperemia
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
stenfilcon A lens (control)
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
Intervention: stenfilcon A lens (control) (Device)
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.
Intervention: stenfilcon A lens with solution additive (test) (Device)
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.
Intervention: stenfilcon A lens (control) (Device)
stenfilcon A lens (control)
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
Intervention: stenfilcon A lens with solution additive (test) (Device)
Outcomes
Primary Outcomes
Bulbar Hyperemia
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 1 Month
Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
Vision Satisfaction
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Subjective Ratings on Comfort
Time Frame: Baseline
Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
Subjective Ratings on Comfort
Time Frame: 1 Week
Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
Vision Satisfaction
Time Frame: Baseline
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
Vision Satisfaction
Time Frame: 1 week
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
Visual Acuity On High Illumination High Contrast
Time Frame: Baseline
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.
Visual Acuity On High Illumination High Contrast
Time Frame: 1 Week
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.
Visual Acuity On Low Illumination High Contrast
Time Frame: Baseline
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 Low Illumination High Contrast
Time Frame: 1 Week
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.
Overall Corneal Staining
Time Frame: One Week
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.
Conjunctival Staining
Time Frame: 1 Week
Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent
Bulbar Hyperemia
Time Frame: 1 Week
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)
Limbal Hyperemia
Time Frame: 1 Week
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)
Palpebral Hyperemia
Time Frame: 1 Week
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 Outcomes
- Lens Surface - Deposits(1 Month)
- Lens Fit Acceptance(1 Month)
- Handling Satisfaction(1 Month)
- Subjective Ratings on Dryness(1 Month)
- Lens Surface - Wettability(1 Month)
- Lens Fit Acceptance(Baseline)
- Lens Fit Acceptance(1 week)
- Handling Satisfaction(1 week)
- Lens Surface - Wettability(Baseline)
- Lens Surface - Wettability(1 Week)
- Lens Surface - Deposits(Baseline)
- Lens Surface - Deposits(1 week)
- Subjective Ratings on Dryness(Baseline)
- Subjective Ratings on Dryness(1 week)