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The Clinical Comparison of Somofilcon A 1 Day and Nelfilcon A Daily Disposable Contact Lenses

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.
 
ClinicalTrials.gov Identifier: NCT04067141
Recruitment Status : Completed
First Posted : August 26, 2019
Last Update Posted : July 13, 2020
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Tracking Information
First Submitted Date  ICMJE August 21, 2019
First Posted Date  ICMJE August 26, 2019
Last Update Posted Date July 13, 2020
Actual Study Start Date  ICMJE July 4, 2019
Actual Primary Completion Date November 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2020)
  • Biomicroscopy - Conjunctival Redness Score [ Time Frame: Up to 1 week ]
    Conjunctival redness - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
  • Biomicroscopy - Limbal Redness Score [ Time Frame: Up to 1 week ]
    Limbal redness - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
  • Biomicroscopy - Corneal Staining Score [ Time Frame: Up to 1 week ]
    Corneal staining - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
  • Biomicroscopy - Conjunctival Staining Score [ Time Frame: Up to 1 week ]
    Conjunctival staining - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
  • Biomicroscopy - Papillary Conjunctivitis Score [ Time Frame: Up to 1 week ]
    Papillary conjunctivitis- slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
  • Horizontal centration - lens fit [ Time Frame: Up to 1 week ]
    Horizontal centration graded by -2 to 2 (-2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal).
  • Vertical Centration Grade - lens fit [ Time Frame: Up to 1 week ]
    Vertical centration graded by -2 to 2 (-2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior).
  • Corneal Coverage Grade [ Time Frame: Up to 1 week ]
    Corneal coverage graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive).
  • Post-Blink Movement Grade [ Time Frame: Up to 1 week ]
    Post-blink movement graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive).
  • Subjective Comfort at Lens Dispensing [ Time Frame: Up to 1 week ]
    Subjective comfort at lens dispensing on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).
  • Subjective Comfort at Start of Day [ Time Frame: Up to 1 week ]
    Subjective comfort at start of day on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).
  • Subjective Comfort at End of Day [ Time Frame: Up to 1 week ]
    Subjective comfort at end of day on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).
  • Overall Subjective Comfort [ Time Frame: Up to 1 week ]
    Overall subjective comfort on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).
  • Subjective Vision [ Time Frame: Up to 1 week ]
    Subjective Vision rated on scale 0-100 (0=unacceptable, lens cannot be worn to 100=excellent, unaware of an visual loss.)
  • Ocular Redness Rating [ Time Frame: Up to 1 week ]
    Ocular redness rating rated on a scale 0-100 (0=extremely poor, intolerable levels of redness to 100 = excellent, no redness)
Original Primary Outcome Measures  ICMJE
 (submitted: August 21, 2019)
  • Biomicroscopy - Conjunctival Redness Score [ Time Frame: Up to 1 week ]
    Conjunctival redness - slit lamp biomicroscopy using Efron Grading Scales scored to nearest 0.1.
  • Biomicroscopy - Limbal Redness Score [ Time Frame: Up to 1 week ]
    Limbal redness - slit lamp biomicroscopy using Efron Grading Scales scored to nearest 0.1.
  • Biomicroscopy - Corneal Staining Score [ Time Frame: Up to 1 week ]
    Corneal staining - slit lamp biomicroscopy using Efron Grading Scales scored to nearest 0.1.
  • Biomicroscopy - Conjunctival Staining Score [ Time Frame: Up to 1 week ]
    Conjunctival staining - slit lamp biomicroscopy using Efron Grading Scales scored to nearest 0.1.
  • Biomicroscopy - Papillary Conjunctivitis Score [ Time Frame: Up to 1 week ]
    Papillary conjunctivitis- slit lamp biomicroscopy using Efron Grading Scales scored to nearest 0.1.
  • Horizontal centration - lens fit [ Time Frame: Up to 1 week ]
    Horizontal centration graded by -2 to 2 (-2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal).
  • Vertical Centration Grade - lens fit [ Time Frame: Up to 1 week ]
    Vertical centration graded by -2 to 2 (-2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior).
  • Corneal Coverage Grade [ Time Frame: Up to 1 week ]
    Corneal coverage graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive).
  • Post-Blink Movement Grade [ Time Frame: Up to 1 week ]
    Post-blink movement graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive).
  • Subjective Comfort at Lens Dispensing [ Time Frame: Up to 1 week ]
    Subjective comfort at lens dispensing on scale 1-10 (0=Causes pain. Cannot be tolerated to 10=Excellent. Cannot be felt.).
  • Subjective Comfort at Start of Day [ Time Frame: Up to 1 week ]
    Subjective comfort at start of day on scale 1-10 (0=Causes pain. Cannot be tolerated to 10=Excellent. Cannot be felt.).
  • Subjective Comfort at End of Day [ Time Frame: Up to 1 week ]
    Subjective comfort at end of day on scale 1-10 (0=Causes pain. Cannot be tolerated to 10=Excellent. Cannot be felt.).
  • Overall Subjective Comfort [ Time Frame: Up to 1 week ]
    Overall subjective comfort on scale 1-10 (0=Causes pain. Cannot be tolerated to 10=Excellent. Cannot be felt.).
  • Subjective Vision [ Time Frame: Up to 1 week ]
    Subjective Vision rated on scale 1-10 (0=unacceptable, lens cannot be worn to 10=excellent, unaware of an visual loss.)
  • Ocular Redness Rating [ Time Frame: Up to 1 week ]
    Ocular redness rating rated on a scale 1-10 (0=extremely poor, intolerable levels of redness to 100 = excellent, no redness)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Clinical Comparison of Somofilcon A 1 Day and Nelfilcon A Daily Disposable Contact Lenses
Official Title  ICMJE The Clinical Comparison of the Clariti 1 Day and DAILIES AquaComfort PLUS Daily Disposable Contact Lenses
Brief Summary This subject-masked, randomized, bilateral crossover study will compare the clinical performance and subjective acceptance of the somofilcon A 1 day soft contact lens with the nelfilcon A daily disposable lens when used on a daily wear, daily disposable basis.
Detailed Description

This will be a randomized, subject-masked, crossover, bilateral study, controlled by cross-comparison. This will compare the clinical performance and subjective acceptance of the somofilcon A 1 day soft contact lens with the nelfilcon A daily disposable lens when used on a daily wear, daily disposable basis.

Subjects will use each lens type for a week in random sequence. Follow-up visits for each lens will be performed after one week of wear. Lenses will be worn on a daily wear, daily disposable wear schedule.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
This is a bilateral crossover study
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE Ametropia
Intervention  ICMJE
  • Device: somofilcon A
    Contact Lens
    Other Names:
    • somofilcon A 1 day
    • test lens
    • clariti 1 day
  • Device: nelfilcon A
    Contact Lens
    Other Names:
    • nelfilcon A Daily Disposable Contact Lens
    • control lens
    • DAILIES AquaComfort PLUS daily disposable
Study Arms  ICMJE
  • Experimental: somofilcon A, then nelfilcon A
    Subjects will bilaterally wear the somofilcon A lenses, then crossover to nelfilcon A lenses after one week of wear. Both lenses will be worn on a daily wear basis for one week.
    Interventions:
    • Device: somofilcon A
    • Device: nelfilcon A
  • Experimental: nelfilcon A, then somofilcon A
    Subjects will bilaterally wear the nelfilcon A lenses, then crossover to somofilcon A lenses after one week of wear. Both lenses will be worn on a daily wear basis for one week.
    Interventions:
    • Device: somofilcon A
    • Device: nelfilcon A
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2019)
70
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 20, 2019
Actual Primary Completion Date November 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • They are of legal age (18) and capacity to volunteer.
  • They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
  • They are willing and able to follow the protocol.
  • They agree not to participate in other clinical research for the duration of this study.
  • They have a contact lens spherical prescription between -1.00 to - 6.00D (inclusive)
  • They have a maximum of -1.00DC ocular astigmatism in each eye.
  • They can be satisfactorily fitted with the study lens types.
  • At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
  • They currently use soft contact lenses or have done so in the previous six months.
  • They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
  • They own a wearable pair of spectacles.

Exclusion Criteria:

  • They have an ocular disorder which would normally contra-indicate contact lens wear.
  • They have a systemic disorder which would normally contra-indicate contact lens wear.
  • They are using any topical medication such as eye drops or ointment.
  • They have had cataract surgery.
  • They have had corneal refractive surgery.
  • They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
  • They are pregnant or breast-feeding.
  • They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
  • They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel, or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
  • They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
  • They currently wear either the clariti 1day or the DAILIES AquaComfort Plus lens.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04067141
Other Study ID Numbers  ICMJE EX-MKTG-75
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Coopervision, Inc.
Study Sponsor  ICMJE Coopervision, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Coopervision, Inc.
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP