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

CooperVision, Inc.72 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Myopia

Interventions

stenfilcon A lens with solution additive (test)DEVICE

silicone hydrogel lens

stenfilcon A lens (control)DEVICE

contact lens

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Clinical Optical Research Lab (CORL)

Bloomington, Indiana, United States

The Ocular Surface Institute (TOSI)

Houston, Texas, United States

Outcomes

Primary Outcomes

Subjective Ratings on Comfort

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

Time frame: Baseline

Subjective Ratings on Comfort

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

Time frame: 1 Week

Subjective Ratings on Comfort

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: Baseline

Data from ClinicalTrials.gov

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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.

Time frame: 1 Week

Visual Acuity On High Illumination High Contrast

Time frame: 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.

Time frame: Baseline

Visual Acuity On Low Illumination High Contrast

Time frame: 1 Week

Visual Acuity On Low Illumination High Contrast

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 1 Week

Palpebral Hyperemia

Time frame: 1 Month

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 1 Month

Lens Surface - Wettability

Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent

Time frame: Baseline

Lens Surface - Wettability

Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent

Time frame: 1 Week

Lens Surface - Wettability

Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 1 Month