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One Week Assessment of a New Study Test Lens

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02642341
First Posted: December 30, 2015
Last Update Posted: July 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Coopervision, Inc.
  Purpose
This study will investigate performance criteria over one week of daily wear to determine if the Study Test contact lens performs equivalently to the comfilcon A contact lenses in terms of measurement and subjective ratings of visual performance.

Condition Intervention
Myopia Device: Study Test contact lens Device: comfilcon A contact lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: One Week Assessment of a New Study Test Lens

Resource links provided by NLM:


Further study details as provided by Coopervision, Inc.:

Primary Outcome Measures:
  • Distance Visual Acuity (VA) - High Contrast (HC) - Study Test Lens [ Time Frame: Up to 1 week ]
    logMAR (Logarithm of the Minimum Angle of Resolution) VA (Visual Acuity)

  • Distance Visual Acuity (VA) - High Contrast (HC) - comfilcon A [ Time Frame: Up to 1 week ]
    logMAR VA

  • Near Visual Acuity (VA) - High Contrast (HC) - Study Test Lens [ Time Frame: Up to 1 week ]
    logMAR VA

  • Near Visual Acuity (VA) - High Contrast (HC) - comfilcon A [ Time Frame: Up to 1 week ]
    logMAR VA

  • Distance Visual Acuity (VA) - Low Contrast (LC) - Study Test Lens [ Time Frame: Up to 1 week ]
    logMAR VA

  • Distance Visual Acuity (VA) - Low Contrast (LC) - comfilcon A [ Time Frame: Up to 1 week ]
    logMAR VA

  • Near Visual Acuity (VA) - Low Contrast (LC) - Study Test Lens [ Time Frame: Up to 1 week ]
    logMAR VA

  • Near Visual Acuity (VA) - Low Contrast (LC) - comfilcon A [ Time Frame: Up to 1 week ]
    logMAR VA

  • Quality of Vision - Distance - Study Test Lens [ Time Frame: Up to 1 week ]
    Patient subjective scoring using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time

  • Quality of Vision - Distance - comfilcon A [ Time Frame: Up to 1 week ]
    Patient subjective scoring using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time

  • Quality of Vision - Near - Study Test Lens [ Time Frame: Up to 1 week ]
    Patient subjective scoring using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time

  • Quality of Vision - Near - comfilcon A [ Time Frame: Up to 1 week ]
    Patient subjective scoring using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time

  • High Illumination High Contrast (HIHC) Visual Acuity - Study Test Lens [ Time Frame: Up to 1 week ]
    High Illumination High Contrast (HICH) Visual Acuity assessed for OD, OS, and OU using logMAR VA

  • High Illumination High Contrast (HIHC) Visual Acuity - comfilcon A [ Time Frame: Up to 1 week ]
    High Illumination High Contrast (HICH) Visual Acuity assessed for OD, OS, and OU using logMAR VA

  • Low Illumination High Contrast (LIHC) Visual Acuity - Study Test Lens [ Time Frame: Up to 1 week ]
    Low Illumination High Contrast (LIHC) Visual Acuity assessed for OD, OS, and OU using logMAR VA

  • Low Illumination High Contrast (LIHC) Visual Acuity - comfilcon A [ Time Frame: Up to 1 week ]
    Low Illumination High Contrast (LIHC) Visual Acuity assessed for OD, OS, and OU using logMAR VA


Secondary Outcome Measures:
  • Biomicroscopy - Bulbar & Limbal Hyperaemia - Study Test Lens [ Time Frame: Baseline, 1 week follow-up visit, 2 week follow-up visit ]
    Investigator assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps)

  • Biomicroscopy - Bulbar & Limbal Hyperaemia - comfilcon A [ Time Frame: Baseline, 1 week follow-up visit ]
    Investigator assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps)

  • Biomicroscopy - Palpebral Hyperaemia - Study Test Lens [ Time Frame: Baseline, 1 week follow-up visit ]
    Investigator assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps)

  • Biomicroscopy - Palpebral Hyperaemia - comfilcon A [ Time Frame: Baseline, 1 week follow-up visit ]
    Investigator assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps)

  • Biomicroscopy - Palpebral Roughness - Study Test Lens [ Time Frame: Baseline, 1 week follow-up visit ]
    Investigator assessment using 5 categories: 0=Uniform satin appearance of conjunctiva, 1=Trace, slight loss of smoothness, 2=Mild, or scattered papillae/follicles <1mm in diameter, 3=Moderate, significant papillae/follicles <1mm in diameter, 4=Severe, localised or generalised papillae/ follicles 1mm or more in diameter) in 0.25 steps

  • Biomicroscopy - Palpebral Roughness - comfilcon A [ Time Frame: Baseline, 1 week follow-up visit ]
    Investigator assessment using 5 categories: 0=Uniform satin appearance of conjunctiva, 1=Trace, slight loss of smoothness, 2=Mild, or scattered papillae/follicles <1mm in diameter, 3=Moderate, significant papillae/follicles <1mm in diameter, 4=Severe, localised or generalised papillae/ follicles 1mm or more in diameter) in 0.25 steps

  • Biomicroscopy - Other significant findings - Study Test Lens [ Time Frame: Baseline, 1 week follow-up visit ]
    Investigator assessment using 4 categories: (1=Trace, 2=Mild, 3=Moderate, 4=Severe) in 0.25 steps

  • Biomicroscopy - Other significant findings - comfilcon A [ Time Frame: Baseline, 1 week follow-up visit ]
    Investigator assessment using 4 categories: (1=Trace, 2=Mild, 3=Moderate, 4=Severe) in 0.25 steps

  • Biomicroscopy - Corneal Staining Type - Study Test Lens [ Time Frame: Baseline, 1 week follow-up visit ]
    Investigator assessment using 5 categories: 0=No staining, 1=Trace, minimal superficial diffuse staining or stippling, or trace abrasion or foreign body tracks, 2=Mild, regional or diffuse punctate staining, or mild abrasion or foreign body tracks, 3=Moderate, significant dense coalesced staining, corneal abrasion or foreign body tracks, 4=Severe abrasions greater than 2mm diameter, ulcerations, epithelial loss, or full thickness abrasion in 0.50 steps.

  • Biomicroscopy - Corneal Staining Type - comfilcon A [ Time Frame: Baseline, 1 week follow-up visit ]
    Investigator assessment using 5 categories: 0=No staining, 1=Trace, minimal superficial diffuse staining or stippling, or trace abrasion or foreign body tracks, 2=Mild, regional or diffuse punctate staining, or mild abrasion or foreign body tracks, 3=Moderate, significant dense coalesced staining, corneal abrasion or foreign body tracks, 4=Severe abrasions greater than 2mm diameter, ulcerations, epithelial loss, or full thickness abrasion in 0.50 steps.

  • Biomicroscopy - Corneal Staining Extent - Study Test Lens [ Time Frame: Baseline, 1 week follow-up visit ]
    Investigator assessment using 5 categories: 0=No staining, 1=1-15% of area, 2=16-30% of area, 3=31-45% of area, 4= >45% of area, using integer scale

  • Biomicroscopy - Corneal Staining Extent - comfilcon A [ Time Frame: Baseline, 1 week follow-up visit ]
    Investigator assessment using 5 categories: 0=No staining, 1=1-15% of area, 2=16-30% of area, 3=31-45% of area, 4= >45% of area, using integer scale

  • Biomicroscopy - Causes for Staining - Study Test Lens [ Time Frame: Baseline, 1 week follow-up visit ]
    Investigator assessment of cornea as a whole: Dehydration staining present (yes/no), Lens related staining (yes/no), Toxic staining (yes/no), Other description

  • Biomicroscopy - Causes for Staining - comfilcon A [ Time Frame: Baseline, 1 week follow-up visit ]
    Investigator assessment of cornea as a whole: Dehydration staining present (yes/no), Lens related staining (yes/no), Toxic staining (yes/no), Other description

  • Biomicroscopy - Corneal Staining Depth - Study Test Lens [ Time Frame: Baseline, 1 week follow-up visit ]
    Investigator assessment using 5 categories: 0=No staining, 1=Superficial epithelium, 2=Deep epithelium, delayed stromal glow, 3=Immediate localized stromal glow, 4=Immediate diffuse stromal glow, or full thickness abrasion in 0.50 steps.

  • Biomicroscopy - Corneal Staining Depth - comfilcon A [ Time Frame: Baseline, 1 week follow-up visit ]
    Investigator assessment using 5 categories: 0=No staining, 1=Superficial epithelium, 2=Deep epithelium, delayed stromal glow, 3=Immediate localized stromal glow, 4=Immediate diffuse stromal glow, or full thickness abrasion in 0.50 steps.

  • Biomicroscopy - Conjunctival Staining - Study Test Lens [ Time Frame: Baseline, 1 week follow-up visit ]
    Investigator assessment using 5 categories: 0=None, 1=Minimal diffuse punctate, 2=Coalescent punctate, 3=Confluent, 4=Deep confluent in 0.50 steps

  • Biomicroscopy - Conjunctival Staining - comfilcon A [ Time Frame: Baseline, 1 week follow-up visit ]
    Investigator assessment using 5 categories: 0=None, 1=Minimal diffuse punctate, 2=Coalescent punctate, 3=Confluent, 4=Deep confluent in 0.50 steps

  • Biomicroscopy - Conjunctival Indentation - Study Test Lens [ Time Frame: Baseline, 1 week follow-up visit ]
    Investigator assessment using 5 categories:0 None, 1=Very slight, 2=Slight, 3=Moderate, 4=Severe in 0.50 steps

  • Centration - Study Test Lens [ Time Frame: Baseline,1 week follow-up visit ]
    Investigator assessment using Grading Categories: Optimally Centered, Slightly Decentered (<0.5mm) Nasal, Temporal, Superior, Inferior (NTSI), Extremely Decentered (>0.5mm) NTSI

  • Centration - comfilcon A [ Time Frame: Baseline,1 week follow-up visit ]
    Investigator assessment using Grading Categories: Optimally Centered, Slightly Decentered (<0.5mm) Nasal, Temporal, Superior, Inferior (NTSI), Extremely Decentered (>0.5mm) NTSI

  • Post Blink Movement - Study Test Lens [ Time Frame: Baseline,1 week follow-up visit ]
    Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)

  • Post Blink Movement - comfilcon A [ Time Frame: Baseline,1 week follow-up visit ]
    Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)

  • Push - Up Test - Study Test Lens [ Time Frame: Baseline,1 week follow-up visit ]
    Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement

  • Push - Up Test - comfilcon A [ Time Frame: Baseline,1 week follow-up visit ]
    Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement

  • Mobility Rating - Study Test Lens [ Time Frame: Baseline,1 week follow-up visit ]
    Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps

  • Mobility Rating - comfilcon A [ Time Frame: Baseline,1 week follow-up visit ]
    Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps

  • Overall Lens Fit Acceptance - Study Test Lens [ Time Frame: Baseline,1 week follow-up visit ]
    Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps

  • Overall Lens Fit Acceptance - comfilcon A [ Time Frame: Baseline,1 week follow-up visit ]
    Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn,, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps

  • Lens Surface Quality - Study Test Lens [ Time Frame: Baseline,1 week follow-up visit ]
    Investigator assessment using 5 Categories in 0.25 steps: 0=Very Poor; 1=Poor; 2=Acceptable; 3=Good; 4=Excellent

  • Lens Surface Quality - comfilcon A [ Time Frame: Baseline,1 week follow-up visit ]
    Investigator assessment using 5 Categories in 0.25 steps: 0= Very poor; 1=Poor; 2=Acceptable; 3=Good; 4=Excellent

  • Front Surface Deposits - Study Test Lens [ Time Frame: Baseline,1 week follow-up visit ]
    Investigator assessment using 5 Categories in 0.25 steps:0=Clean, no deposits, 1=5 or less small deposits (<0.1mm), 2=>5 deposits of <0.1mm size or film covering 25-50% of surface, 3=Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface

  • Front Surface Deposits - comfilcon A [ Time Frame: Baseline,1 week follow-up visit ]
    Investigator assessment using 5 Categories in 0.25 steps:0=Clean, no deposits, 1=5 or less small deposits (<0.1mm), 2=>5 deposits of <0.1mm size or film covering 25-50% of surface, 3=Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface

  • Deposit Type - Study Test Lens [ Time Frame: Baseline,1 week follow-up visit ]
    Grade type of deposits using 4 categories (integer): 1=lipid, 2= mucous, 3=protein, 4=other)

  • Deposit Type - comfilcon A [ Time Frame: Baseline,1 week follow-up visit ]
    Grade type of deposits using 4 categories (integer): 1=lipid, 2= mucous, 3=protein, 4=other)

  • Back Surface Debris - Study Test Lens [ Time Frame: Baseline,1 week follow-up visit ]

    Grade amount of back surface debris trapped between lens and cornea in 0.25 steps using 5 categories: 0=No debris

    1. small (<0.1mm) particles
    2. Coalescing areas <1/3 of lens area
    3. Coalescing areas between 1/3 to 2/3 of area beneath lens
    4. Debris under lens >2/3 area

  • Back Surface Debris - comfilcon A [ Time Frame: Baseline,1 week follow-up visit ]

    Grade amount of back surface debris trapped between lens and cornea in 0.25 steps using 5 categories: 0=No debris

    1. small (<0.1mm) particles
    2. Coalescing areas <1/3 of lens area
    3. Coalescing areas between 1/3 to 2/3 of area beneath lens
    4. Debris under lens >2/3 area

  • Ghosting - Distance Vision - Study Test Lens [ Time Frame: 1 week follow-up ]
    Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable

  • Ghosting - Distance Vision - comfilcon A [ Time Frame: 1 week follow-up ]
    Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable

  • Ghosting when reading - Study Test Lens [ Time Frame: 1 week follow-up ]
    Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable

  • Ghosting when reading - comfilcon A [ Time Frame: 1 week follow-up ]
    Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable

  • Overall Comfort - Study Test Lens [ Time Frame: Baseline,1 week follow-up visit, 2 week follow-up visit ]
    Patient subjective scoring using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever.

  • Overall Comfort - comfilcon A [ Time Frame: Baseline,1 week follow-up visit, 2 week follow-up visit ]
    Patient subjective scoring using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever.

  • Overall Dryness - Study Test Lens [ Time Frame: Baseline,1 week follow-up visit, 2 week follow-up visit ]
    Patient subjective scoring using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time.

  • Overall Dryness - comfilcon A [ Time Frame: Baseline,1 week follow-up visit, 2 week follow-up visit ]
    Patient subjective scoring using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time.

  • Lens Preference - Distance Vision [ Time Frame: 2 week follow-up visit ]
    Subjective rating for lens preference for distance vision assessed at 2 week follow-up visit. (Study test lens or comfilcon A)

  • Lens Preference - Digital device overall preference [ Time Frame: 2 week follow-up visit ]
    Subjective rating for lens preference for digital device overall preference assessed at 2 week follow-up visit. (Study test lens or comfilcon A)

  • Lens Preference - Tired eyes relief preference [ Time Frame: 2 week follow-up visit ]
    Subjective rating for lens preference for tired eyes relief preference assessed at 2 week follow-up visit. (Study test lens or comfilcon A)

  • Lens Preference - Overall Vision Preference [ Time Frame: 2 week follow-up visit ]
    Subjective rating for lens preference for overall vision preference assessed at 2 week follow-up visit. (Study test lens or comfilcon A)

  • Lens Preference - Comfort Preference [ Time Frame: 2 week follow-up visit ]
    Subjective rating for lens preference assessed at 2 week follow-up visit. (Study test lens or comfilcon A)

  • Lens Preference -Overall Lens Preference [ Time Frame: 2 week follow-up visit ]
    Subjective rating for lens preference assessed at 2 week follow-up visit. (Study test lens or comfilcon A)


Enrollment: 40
Study Start Date: November 2015
Study Completion Date: March 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Test contact lens
Study Test Contact Lens
Device: Study Test contact lens
Active Comparator: comfilcon A contact lens
Control Contact Lens
Device: comfilcon A contact lens

Detailed Description:
This study is a prospective, single site, daily wear, double masked, randomized bilateral cross over dispensing study of binocular wear of Study Test Lens and comfilcon A sphere contact lenses over 1 week of daily wear. Assessments will be obtained upon dispensing each lens pair and following 1 week of daily lens use.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

  • Oculo-visual examination in the last two years
  • Between 18 and 35 years of age and has full legal capacity to volunteer
  • Has read and understood the informed consent letter
  • Is willing and able to follow instructions and maintain the appointment schedule
  • Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected
  • Currently wears, or has previously successfully worn, soft contact lenses between -1.00D (Diopter) and -4.00D
  • Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder <-0.75
  • Has not worn lenses for at least 12 hours before the initial visit
  • Has a subjective response at baseline, which indicates suitability for this study
  • Currently spends a minimum of 4 hours a day; 5 days a week on digital devices and can replicate this time during the study period
  • Is willing and able to wear the study contact lenses a minimum of 10 hours per day; 5 days a week.

Exclusion Criteria:

A person will be excluded from the study if he/she:

  • Has never worn contact lenses before
  • Any systemic disease affecting ocular health
  • Is using any systemic or topical medications that will affect ocular health
  • Has known sensitivity to the diagnostic pharmaceuticals or study products used in this study.
  • Has any ocular pathology or anomaly that would affect the wearing of the lenses
  • Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye
  • Is aphakic
  • Has anisometropia of >1.00
  • Has undergone corneal refractive surgery
  • Has strabismus
  • Has any ocular amblyopia >= 1line of HC (High Contrast) Visual Acuity
  • Is participating in any other type of eye related clinical or research study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642341


Locations
United States, Indiana
CORL, Indiana University School of Optometry
Indianapolis, Indiana, United States, 46266-6057
Sponsors and Collaborators
Coopervision, Inc.
Investigators
Principal Investigator: Pete Kollbaum CORL, Indiana University
  More Information

Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT02642341     History of Changes
Other Study ID Numbers: CV-15-74
First Submitted: December 7, 2015
First Posted: December 30, 2015
Last Update Posted: July 27, 2016
Last Verified: July 2016